chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 57-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 31-JAN-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023AMR055743:same reporter
This spontaneous report was received from a consumer referring to his wife (a female patient of unknown age). No concurrent or historical conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot # and expiration date were not provided) dose, route, anatomical location and indication were not provided. No concomitant medications were reported. On an unknown date, the patient experienced a rash on her arm after vaccination. At the time of the report, the outcome of rash was unknown. This is one of two cases received from the same reporter. Additional information has been requested.
The night of the day after the vaccine was given, client started feeling an upset stomach with nausea and cramps, felt very weak; didn't sleep that night, unable to eat d/t nausea and diarrhea started the following day. Felt better on day 3 and resolved by day 4.
pt recv vax & pt exp an unspecified event;3/24/98 pt recovered from the unspecified event;
Information has been received from a mother concerning her 16 year old daughter with a sulfonamide allergy who on approximately 17-DEC-2007 was vaccinated with her first dose of GARDASIL (lot# not reported) and fainted.  She also experienced headaches and injection site pain.  Subsequently, the patient recovered from fainting, headaches and injection site pain after a couple days.  Additional information has been requested.
Sore arm for two days Intense muscle aches/pain for two days Light fever for 1 day Persistent headache/neck pain for 7 days After 5 days, post nasal drip, sore throat, face congestion which lasted another 2-3 days
My husband was positive so I was exposed to COVID-19, I started having a headache and was tired  so I tested with home COVID-19 test that came back positive. I called my doctor who said I did qualify for the Paxlovid and called it in to my pharmacy and I started taking it immediately.  For about eight days after the medication I was tired but I am feeling better now.
Patient received vaccines 8/24/18, next day parents felt child was not moving L leg as much and thought it was due to soreness, on 8/26/18 was not moving left arm or leg and no longer able to sit unassisted. Hemiparesis on L noted at Medical Center, CT scan showed basal ganglia infarct with narrowed R Middle cerebral artery, confirmed by MRI and CT angiogram. Patient was initially admitted to PICU and once stable sent to floor and discharged home on 8/30/18. In hospital stay, seen by infectious disease, cardiology, hematology, genetics, neurology, physical medicine and rehabilitation, PT, OT and speech therapy. 8/28 noted to have abnormal movements of L arm with flexing and stiffening. EEG done at that time did not detect seizure, patient was placed on KEPPRA twice a day for seizure prevention. Also baby aspirin(1/2 tablet per day) and lansoprazole once a day. Patient discharged with L hemiparesis in stable condition and parents started to note some improved movement of arm and leg. As part of initial evaluation patient had LP, and CSF showed negative culture, HSV pcr, VZV IgG on CSF pending but VZV negative. Viral panel was negative except for + coronavirus and parainfluenza virus. Lyme ab test negative. Genetic work up showed normal plasma amino acids, urine amino acids, normal homocysteine, rest of metabolic work up pending. TSH/Free t4 were normal. PT/PTT WNL. Thrombophilia work up is pending. Child will need PT/OT. Cause felt to be related to narrowing of MCA at M1 level but not an embolic stroke so anticoagulation not recommended, and patient placed on aspirin. Echocardiogram showed PFO. Note there was no fever after the vaccines or during hospitalization. While in the hospital developed nasal congestion and symptoms of cold which would explain positive tests for the 2 viruses mentioned above. Patient has been feeding well and showing improvements in arm and leg movements since discharge home.
The next day after the vaccine I started experiencing extreme muscle aches especially in the legs.  I was very fatigued and extremely tired for the entire time as well.  My body felt very weak, and my muscles just ached all day preventing me from performing any duties at all, all of which lasted which lasted about 2 1/2 weeks.  I also experience off and on bad headaches during this time as well.  Various bloodwork panels were performed but all value seem normal.  I was prescribed a 5-day bout of prednisone for presumed Myositis and took Advil, but it did not help, and all symptoms finally subsided.  I also developed laryngitis for about 2 weeks, but no cold symptoms were associated.
Pain, swellin, and rash at injection site. Pain subsided after 2 days but rash has spread accross left arm. advised pt she could take ibuprofen for pain/inflammation and benedryl to try to stop the rash
2 days, post vax, she had a temperature of 102F, followed by vomiting and diarrhea (severe) for 5 days. After antibiotic treatment for 7 days, rash on face. She has suffered since with severe itching, etc. We have since gone to the hospital and they are now treating for extreme car sickness from extreme stress to system.
This spontaneous report as received from a consumer (patients mother) refers to a female patient of unknown age. No medical history provided. On an unknown date the patient was vaccinated with GARDASIL (dosage unknown). No concomitant medications were provided. The reporter could not confirm the patient had received all three shots of GARDASIL. On an unknown date the patient experienced unspecified adverse reactions. The reporter then stated that she knows that the GARDASIL that the patient received was part of the GARDASIL "recall". The reporter then stated that she does not have the lot number, expiry date or any specific information in regards to the GARDASIL that the patient received. The outcome of unspecified adverse reactions is unknown. Additional information has been requested.
On the 7th and for several days after I experienced shortness of breath, increased heart rate, weakness, numbness, and chest pain that continued to worsen, resulting in several ER visits between July and September trying to determine the cause.
Pt got a rash on Day 8 after vaccine was given pimple/blister type patch @ site of injection only.
This spontaneous report as received from a healthcare worker refers to unspecified number of patients unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # L020015, expiry date 16-AUG-2017 (strength, dose, route and site of administration were not reported) in immunization series. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
approx 6-8 hrs post vax pt noted to be limp, ashen in color, cool; pt activity witnessed; pt nl w/in 8 hrs adm overnoc for observation;
1st dose 05/14/21, 2nd dose 6/11/21. No symptoms alert, awake coherent.
FATIGUE, NUMBNESS OF ARM AND LEG, PINS AND NEEDLES FEELING ON WHOLE LEFT SIDE OF BODY FROM JAW TO FEET, ANXIETY ATTACK FEELING
Vial was initially stored in refrigerator on 22-FEB-2023 and administered to patient on 05-APR-2023; No adverse event; accidentally administered a booster dose which was past the 30 day BUD; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered a booster dose which was past the 30 day BUD), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-FEB-2023 and administered to patient on 05-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose, lot number AS1412B ) on 09-Sep-2022, Moderna COVID-19 Vaccine (2nd dose and  lot number AR9236B ) on 14-Oct-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 05-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 05-Apr-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered a booster dose which was past the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-FEB-2023 and administered to patient on 05-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered a booster dose which was past the 30 day BUD), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-FEB-2023 and administered to patient on 05-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (accidentally administered a booster dose which was past the 30 day BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-FEB-2023 and administered to patient on 05-APR-2023).    Concomitant medication details not reported by the reporter. Vaccine was given at 0.2 ml, intramuscularly on the right thigh. Vial was initially stored in refrigerator on 22-FEB-2023. Treatment details was not reported by the reporter.
Patient got 0.2 mL of adult Pfizer vaccine (adult dose is 0.3 mL) instead of pediatric. Patient did not have any adverse reaction.
Increased swelling over right deltoid regoin up into lower later cervical area on the right side with concurrent lymphadenitis and pain in corresponding region.
Nausea, pins and needles, extreme aches, migraine over the course of 4 weeks since first shot.
Had "severe tremor" for 4 hours after receiving both vaccines. Also has high EtOH use and was out of opioid medication at the time. & tremor
Pt vaccinated with TD developed swollen, red, necrotic area where TD was given. Contained pus fluid. Prescribed Erythromycin 250mg q.i.d. X 10 days
No additional AE reported.; expired dose of MMR II was administered to a patient on 07SEP202; This spontaneous report was received from an other health professional via company representative and refers to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 07-SEP-2022, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection, lot #T016352, expiration date: 12-MAY-2022, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No further information was provided. No additional adverse event or product quality complaint was reported.
Mild Headache feels like pressure in the back of my head and a sense of stress in my eys?
Initial information received on 24-Jul-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA207505, 2018SA207528, 2018SA207544. This case involves a 35 years old patient who received 0.5 ml expired dose of vaccine TENIVAC lot U5280AA, expiry date- 16-Mar-2018 via intramuscular route in the left deltoid on 02-Jun-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of actual medication error due to expired vaccine used. It was unknown if patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
pain in her joints and muscles; more muscle pain than joint, most notably her back/pain in her joints and muscles; sore arm with her first and second vaccination; having trouble sleeping; more muscle pain than joint, most notably her back; This is a spontaneous report from a contactable consumer or other non hcp (Patient).   A female patient of an unspecified age received bnt162b2 (BNT162B2 Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 on an unspecified date (Batch/lot number Unknown) for covid-19 immunisation and experienced sore arm. The patient experienced pain in her joints and muscles, more muscle pain than joint, most notably her back, sore arm with her first and second vaccination, having trouble sleeping on an unknown date (on Sunday). It was reported that pain in joints and muscles which has turned into more muscle pain than joint, most notably her back. It was reported that at times her muscle pain eases up but then other times it comes on and sort of wrenches up on her. The patient heard "other people" say they had fever and chills but was unaware muscle pain could be a side effect. The patient wanted to know if it was normal to have lingering muscle pain 4 days post injection and how common this side effect was and how long it might last. The outcome of event sore arm with her first and second vaccination was recovered on an unknown date and outcome of other events reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
1st dose of the vaccine on 15Feb2021 and tested positive for COVID 3 days later; This is a spontaneous report from a contactable consumer. A female of an unspecified age (age was reported as Age: 66; Unit: Unspecified) received bnt162b2 (COMIRNATY, Lot number: EJ6136), intramuscularly on 15Feb2021 as a single dose as Covid-19 prophylactic vaccination (COVID-19 immunisation). The patient's medical history and concomitant medications were not reported. she received the 1st dose of the vaccine on 15Feb2021 and tested positive for COVID 3 days later. She is asking what should be done with the 2nd dose and when to take it. Follow-up attempts are completed. No further information is expected.
rash across left Breast, under arm and across back on Sunday 1/31/21  @2100, dr visit on 2/2/21 diagnosed with shingles . Started Valacyclovir 1gm Three times a day for 7 days. Emergency Room to follow up on dissemination of shingles 2/5/21, blood work no IV course needs. Given prednisone to take at home if needed , not taken
Information has been received from a physician concerning a female who was vaccinated IM with a dose of Gardasil (Lot # not provided). There was no concomitant medication. Patient had become light headed and needed to sit down after immunization. Patient outcome was recovered. No product quality complaint was involved. Additional information is not expected.
Prior to testing positive for COVID-19, I had had a cough that had persisted for several months. I took a home antigen test on 3/14/2023 and got a negative result. That night, I began to feel bad. I had fatigue, body aches, sore throat, and head congestion. I took a home antigen test on 3/15/2023 and got a positive result. I was prescribed Paxlovid on 3/16/2023. I stayed home and rested and took the medicine. The medication left a bad aftertaste, but I followed the doctor's orders. I steadily got better, and I was fine within a week. I then resumed my normal activities, and I continued to have the pre-existing cough. I saw my PCP about my cough, and I was referred to a pulmonologist, whom I saw on 4/3/2023. She also arranged for me to take a breathing test and prescribed an Advair inhaler, plus an albuterol inhaler to use in emergencies. When I underwent the breathing test, no anomalies were detected. When I saw the pulmonologist, he prescribed me montelukast. The pulmonologist also took me off the Advair inhaler and told me my lungs were clear. He suspected that my cough was caused by sinus issues, such as maybe sinusitis, rhinitis, or a deviated septum. Since I've been taking the montelukast, I have less sinus drainage. I still have a cough, but it's less severe now. I also have an infected upper right molar and am due to undergo a root canal in the near future. I suspect that the infected molar has something to do with the cough and sinus congestion (especially in the ears), but the doctors disagree. I was also put on amoxicillin/clavulanic acid, which is supposed to treat the infected tooth. The pulmonologist ordered blood tests for allergies, and nothing unusual was detected.
When client went to get up after shots given she started posturing with her head and neck getting stiff eyes rolling back with arms having jerking motions. Laid back on exam table awoke within a minute and was confused. after 2-3 minutes was oriented to time, place and name. Continued to feel dizzy EMS was called. She was checked out and released after 20-30 minutes. Went home.
Patient did not experience any side side effects during the 15 minutes of recovery period, however, later that evening, began to have difficulty breathing, coughing, so she took some OTC Benadryl and went to sleep.  She did not go to the hospital, but an urgent care until the next day where they treated her with Benadryl and steroids.  She continued to have a barking cough and slight wheezing for a short time afterward.  She was transported to MD office where she was treated.  Advised not to get the second vaccination unless she goes for J&J.  Inquired about her status on 6/3 and continues to not have nay difficulty breathing.  Patient did remark that she has a lot of environmental allergies, not so much as medications.
pt recv vax 9-10AM 13JAN98 & reported to school nurse office 1055AM c/o h/a, stomach, vomited x4 w/in 1hr, T98 dismissed 1155AM;
Patient asked to remain in observation area x15 minutes.  Approximately 5 min into observation complained of dizziness, tingling in fingers, sweating.  Pulse 110, skin clammy.  Requested patient move from chair to floor, remove jacket,  instructed purse-lipped breathing, drank 2 bottles of water patient compliant and tolerated well. Pulse reduced to 79 at 1309, finger tingling resolved, asked patient to wait until 1:30 to leave, pt agreed.  Symptoms resolved quickly and completely.
Develop localized erythema on day of vaccination. Increased size and was taken to the ED on the following day. Given KEFLEX without response. Switched to clindamycin in 24 hours later with improvement in redness of the cellulitis.
People injured taking the single vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injury 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 injury (Verbatim: People injured taking the single vaccine). The outcome of the injury was not reported.   It was unknown if the reporter considered the injury to be related to Shingles vaccine.     It was unknown if the company considered the injury to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that, the check out all the lawsuits for people who get injured taking the shingles vaccine. This report was one of several cases received as part of a line-listing, each containing minimal information. This case has been linked with case US2023AMR045907 reported by the same reporter Note: This case and linked case had same source document and since the linked case was processed as per the 2nd comment from the source document, this case was processed as per the first comment (check out all the lawsuits for people who get injured taking the shingles vaccine) as a master case for people who got injuried from taking shingles vaccine. ; Sender's Comments:  US-GLAXOSMITHKLINE-US2023AMR045907:Same reporter
presets with 26% peripheral blasts suggesting progression of primary myelofibrosis. had transient mild thrombocytopenia following vaccinationsand has since recovered
13 year old patient received the Moderna vaccine instead of Pfizer. Moderna at this time has not been indicated for this age range.
RADIATING ACHE AND PAIN FROM ELBOW TO SHOULDER.  AFTER 2 WEEKS PAIN CONTINUES AND IS NOW CAUSING SOME NECK PAIN.  PRESCRIBED PREDNISONE 20 MG BY DOCTOR FOR 8 DAYS.  MID TREATMENT (DAY 3) AS OF THIS WRITING WITH 80% RELIEF.
This solicited report was received from a 52 year old female patient concerning herself. The patient was enrolled in a program. Patient's concurrent conditions, medical history and concomitant medications were not provided. On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot# and expiration date were not provided). On an unknown date, the patient got immediately sick (malaise) after having a vaccination with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) so she considered that vaccinations were scary. At the reporting time, the outcome of malaise was unknown. The causality was not stated. Additional information is not expected as the reporter refused additional contact.
Patient reported an "itchy throat" and she said she "felt like my throat has something caught in it." Patient endorsed difficulty swallowing. Patient also endorsed dizziness and a headache that quickly subsided. EMTs on site took a set of vitals, vitals remained stable and within normal limits. Liquid Benadryl was given (20mL -- 25mg). Patient had an occasional dry cough that subsided after bendryl. Reported "not getting worse" and eventually feeling better. Vitals were retaken while sitting in a secluded room to ensure privacy.
vaccine was expired, no temperature excursion occurred and Moderna determined the vial "maintained the activity necessary to protect against the SAR CoV-2 virus at the time of administration".  Patient reported no adverse reactions.
ONE HOUR AFTER VACCINE, MOM NOTICED A HARD LUMP, APPROX. THE SIZE OF A TENNIS BALL AT INJECTION SITE. IT WAS NOT RED,BUT FELT WARM. NO FEVER. HE COMPLAINED OF TENDERNESS AT THE SITE.