chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever up to 101.2 (persistent) Headache Chills Pain at site of injection
no adverse events; PNEUMOVAX 23 that experienced a temperature excursion was administered to 1 patient; This spontaneous report was received from a medical student and refers to a 88-year-old female patient. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications was reported.   On 09-AUG-2022, the patient was vaccinated with improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, vial, at a dose of 0.5 ml, lot # U039721, expiration date 10-AUG-2023 for prophylaxis (dose #, anatomical location and route of administration were not provided).  The vaccine experienced a temperature excursion of 32.7 Fahrenheit (F) for 24 hours minutes (product storage error). There was no previous temperature excursion. No additional adverse event was reported.
stomach pains; Bad reaction; vomiting; profusely sweating/head dripping with sweat; diarrhea; She reported left arm soreness; left arm swelling after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (She reported left arm soreness), VACCINATION SITE SWELLING (left arm swelling after vaccination), ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction) and VOMITING (vomiting) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Chronic lymphocytic leukemia (Cancer diagnosis). Concurrent medical conditions included Penicillin allergy, Hypertension and High cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL + HIDROCLOROTIAZIDA) and ACEBUTOLOL for BP raised, IBRUTINIB for Cancer, LOVASTATIN for High cholesterol.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE PAIN (She reported left arm soreness) and VACCINATION SITE SWELLING (left arm swelling after vaccination). On 06-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction), VOMITING (vomiting), HYPERHIDROSIS (profusely sweating/head dripping with sweat) and DIARRHOEA (diarrhea). On 07-Feb-2021, VACCINATION SITE PAIN (She reported left arm soreness), VACCINATION SITE SWELLING (left arm swelling after vaccination), ABDOMINAL PAIN UPPER (stomach pains), ADVERSE REACTION (Bad reaction), VOMITING (vomiting), HYPERHIDROSIS (profusely sweating/head dripping with sweat) and DIARRHOEA (diarrhea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
administered only diluent portion; administered only diluent portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Rota (Rotarix lyophilized formulation) (batch number 22952, expiry date 16th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 22nd July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, 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.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 27-Jul-2022 Reporter's Comments: The nurse reported that another nurse accidentally administered on 22nd July 2022 only the diluent portion of Rotarix to 2 patients. The reporter consented to follow up. Additional Supportive Information: The nurse reported that another nurse accidentally administered on 22nd July 2022 only the diluent portion of Rotarix to 2 patients, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022111743:Same reporter
Information has been received from a physician concerning a female (age unknown), who, on an unspecified date, was vaccinated with a dose of GARDASIL. Subsequently, the patient did not feel well 15 minutes after the vaccination. The patient sought medical attention during the time she was in the office. The patient recovered on an unspecified date on the same day as the vaccination. No product quality complaint was involved. Additional information has been requested.
Patient experienced redness and swelling at inject site immediately after injection. A little over 24 hours later she experienced a separate red, swollen site about 2 inches below the original site. This new red spot was about 2 inches in diameter and was swollen and sore. On 9/6/18 the new spot was not as swollen or as sore but was still red.
20 Patients received Spikevax past the 30 day expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date) 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 assessment was provided for EXPIRED PRODUCT ADMINISTERED (20 Patients received Spikevax past the 30 day expiration date).    This case was created for 15th patient of 20 patients Concomitant medication was not provided. Treatment medication was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-700683 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-700683:Master case
AFTER FIRST DOSE 20 APRIL 2021:  After first dost, had pain in my left arm for 3 days and it got better in a week time. PROBLEM-1, my left ear started little ringing.  PROBLEM-2, my right foot have problem in walking. Initially thought it is my old shoes but after changing to new shoes problem still persist.    AFTER SECOND DOSE 18 MAY 2021:  Heavy shivering, fever, body pain, pain in right arm 3 days then started getting better and got these conditions improved in 7-10 days.  PROBLEM-1, Ear ringing, buzzing, hollow sound, unable to recognize surround sound problem and listening capabilities in left ear reduced heavily.  PROBLEM-2: Right leg problem increased and feeling numbness and tickling on right foot. I could
Dizziness, lightheaded; bp 89/51 then increased to 112/79
Red eyes, shortness of breath, dry mouth, swollen throat, shaking hands, blurred vision.
This spontaneous report as received from an unspecified reporter refers to a patient of unknown age and gender. The patient's relevant medical history was not reported. On 27-OCT-2015 the patient was vaccinated with M-M-R II (therapy type, route, dose, frequency and lot # were not reported) which underwent an excursion. This is one of several reports received form the same source. Additional information has been requested.
Patient left message on 12/30/15 to state arm was painful with periods of numbness. Unable to lift past a 45 degree angle. Had not seen a physician at this time. On 1/4/16 facility provided resources encouraging patient to be seen by medical provider. Facility spoke to patient on 1/12/16. Still with pain and still has not been seen by physician. Doctor appointment set up for patient on 1/15/2016 at Medical Clinic. Patient left a message on 1/16/2016 that doctor states she had nerve damage. Anti-inflammatory and pain med presribed.
The morning following vaccination, the patient had sudden onset of severe vomiting, dizziness, and flu type symptoms that were severe enough to call the EMT.  It was the EMT that stated he thought it was related to the flu vaccine.
I26.99 ACUTE PULMONARY EMBOLISM 4/26/2023 HX OF LUNG CANCER, RIGHT LUNG
Had shot, had shingles/suspected vaccination failure; ShinglesTwice; skin has something crawling underneath; Pain is the worst; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure 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 vaccination failure (Verbatim: Had shot, had shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: ShinglesTwice), skin discomfort (Verbatim: skin has something crawling underneath) and pain (Verbatim: Pain is the worst). The outcome of the vaccination failure was unknown and the outcome of the shingles, skin discomfort and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, skin discomfort and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, skin discomfort and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that it was like his/her skin had something crawling underneath and the pain was the worst but had the shingles shot and only had the shingles twice. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Woke up this morning with hip pain/just a dull pain on either side of my hips; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 06Aug2021 13:00 (Batch/Lot number: unknown) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ARTHRALGIA (non-serious) with onset 11Aug2021, outcome "unknown", described as "Woke up this morning with hip pain/just a dull pain on either side of my hips". Additional information: Caller received the first dose of the Pfizer covid 19 vaccine and stated he had a couple little side effects, on day five. Caller states he received the first dose last Friday at 1pm, he is at day 5 now, woke up this morning with hip pain. Caller states, they gave me 5 sheets when he received the vaccine and joint pain was one of the side effects, it was at my waist. Is that one of the side effects, pain in hips. Caller asks the pain at your waistline is that considered the same. It's not that bad, just a dull pain on either side of my hips. Caller states he did not want to report at this time, and he was not sure if it is even related to the vaccine or not and states, maybe he slept wrong and woke up with hip pain. When asked if the side effects start later than a couple of days and how long do side effects last. Patient responded that side effects that patient may experience throughout the rest of his body (systemic side effects) were observed with the first 1 to 2 days after vaccination and resolved shortly thereafter.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This is patient (self) report: ?Covid arm? noticed on day 10 post vaccine.  Itchy, achy. Classic size as determined by newspaper article/ about 4 inches long/2inches wide. Red, firm swollen area very gradually fading in color. Size, sensations and swelling remain the same. Last two day have had mild yet annoying headache starting mid day. No temp.
I started on Sunday night with congestion, fatigue, sore throat. I thought it was allergy but when my grandson spoke allergies that he doesn?t have I decided to have the test, I tested Positive, and on Monday I called the doctor and doctor called the pharmacy and we took medicine prescribed. No fever. I was under medicine for 5 days.
Extreme chills, unable to stand up ,difficulty breathing, , dizzy, extreme weakness in arms and legs, felt like wet noodles, intense pain in joints and muscles, couldn?t function.
Information was received on 11-JUL-2017 from a licensed practical nurse who was reporting on multiple unspecified patients of unknown age and gender. No medical history or concomitant medications were reported. The nurse reported that an unspecified number of patients received on unspecified dates, an unspecified separate number of doses of improperly stored VARIVAX (lot # N012488, expires 20-APR-2019, lot # N001527, expires 13-JAN-2019 and lot # N012134, expires 17-APR-2019). It was also reported that unspecified number of separate patients were administered separate doses of PROQUAD (MARRS# 1707USA009347). The lot numbers of the sterile diluent used to reconstitute the vaccine was unknown. No adverse effects were reported. No other information was provided. The temperature excursion was 6 degrees F. to 14 degrees F. for 8 hours and 52 minutes and 30 seconds. This was due to data logger. Additional information has been requested. This is one of two reports by the same reporter.
Information has been received from a registered nurse concerning her 12 month old daughter with no pertinent medical history and no allergies who on 8/26/03 was vaccinated with a dose of varicella virus vaccine live. On 9/4/03 the patient experienced her first seizure. The mother stated that the child had a second seizure on 9/11/03, and a third seizure on 9/19/03. The child had no fever, and was not taken to the hospital or the emergency room. The child's physician was called for follow up. Unspecified medical attention was sought. There was no product quality complaint. No lab diagnostic studies were performed. Upon internal review, the patient's convulsions were considered to be other important medical events (OMIC). Additional information has been requested.
Per client, 30 minutes after vaccine, felt numbness and pain in Lt arm. Stated after vaccine also felt numbness from Lt shoulder to hip. 2 weeks following vaccine, developed rash in Lt arm with some swelling and this was in area of vaccine. Current complaint now is that she has pain from middle of her back to lower back, said this occurs when she lays in bed to watch TV.
Pt. fainted after ADACEL given IM, seizure, came out within minutes, sweaty, pale, conscious, feel nauseated. Gradually return to normal after 15 minutes, sent home after about 40 minutes.
Headaches neck pain followed by emergency room visit, schingles and meningitis. 8 days in hospital  on iv aciclovir followed by 2 weeks more at home. then 3 weeks of oral aciclovir. off work since April 28Th.
NO ADVERSE EFFECTS REPORTED BY PATIENT. ON 05/28/2021 , PATIENT CAME IN TO GET 1ST DOSE OF COVID VACCINE. SHE PREFFERED TO GET THE PFIZER VACCINE, BUT WAS ADMINISTERED THE MODERNA VACCINE.  PATIENT WAS FOLLOWED UP WITH AND INFORMED TO GET THE 2ND DOSE OF MODERNA IN 28 DAYS TO COMPLETE THE SERIES.
Dizziness; Fell to knees; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FALL (Fell to knees) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 15-Feb-2021, the patient experienced DIZZINESS (Dizziness) and FALL (Fell to knees). On 15-Feb-2021, DIZZINESS (Dizziness) and FALL (Fell to knees) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
pt. recd. vac & developed parotitis,pruritis,petechial rash,syncope,eosinophilia,& increased ESR.
RIGHT WRIST SWELLING; WRIST PAIN; FOREARM SWELLING; SITE WAS PAINFUL TO HE TOUCH; This spontaneous report received from a patient 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 was not reported, administered on 22-MAR-2021 on right deltoid for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On an unspecified date, the subject experienced right wrist swelling, wrist pain, forearm swelling, and site was painful to he touch. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from right wrist swelling, and wrist pain, and the outcome of forearm swelling and site was painful to he touch was not reported. This report was non-serious.
I stopped getting the flu when I stopped getting the flu shot; Initial information received on 29-Dec-2021 regarding an unsolicited valid non-serious case received from a consumer/non-hcp via social medial.  This case involves Adult of unknown gender patient who reported  i stopped getting the flu when i stopped getting the flu shot ,while receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (dose, formulation, lot number not reported via unknown route in unknown administration site) as prophylactic vaccination.  On an unknown date ,the patient developed a non-serious event " i stopped getting the flu when i stopped getting the flu shot" (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (I stopped getting the flu when I stopped getting the flu shot).  At time of reporting, the outcome was Unknown for the event i stopped getting the flu when i stopped getting the flu shot.
Around 7:30 in the evening at work I started having a migraine. I could hardly lift my arm and the site was immediately swollen. My whole arm became red, hot and painful. I left work. I was very tired . All night long I was up nauseous, my throat hurts, pain in my chest. For a time I felt as if I couldn?t catch my breath. The worst is every bone in my body feels broke and continues to fill like my bones keep breaking over and over. The pain is unbearable. It?s 8:45 in the evening 24 hours later and I feel worse. I literally can not move my body hurts so bad. I?m sweating and then have chills. My left arm has pins and needles down to my finger tips. I have to take another day off of work tomorrow. When I got my first shot in May, a week later to the day my arm that I received the shot was very swollen, itchy, hives, red, hot, all the way down to my elbow.  My son got his second shot also the same day as me and he is also sick today. Not as bad as myself, but was sent home from work. He feels like he can not breath, body aches and tired. I?m just wondering why I?m so sick?
Received ADACEL (Tdap) on 8/11/14 at 1:30 pm on (L) deltoid. Woke on 8/12/14 at 4 am with headache and nausea, dry heaves and sli. diarrhea. Injection side sli. tender to touch without swelling/redness.
At approximately 2:40 pm Patient and Father in waiting room after getting vaccines, waiting on certificate of immunization. Father yelled for help. Father stated patient fainted but he caught him before he could fall. Patient was standing then became sick.  Patient then vomited a small amount of clear liquid. Father states patient had not eaten anything all day. Patient  offered water and cracker. Patient declined the crackers but drank the water and felt better afterwards.
18AUG94 PC from clinc to report pt had been to clinic today dx cellulitis in rt thigh site of DTP; pt was given Amipcillin for 10 days; mom to clinic-states noticed redness swelling et hotness around bandaid-site DTP; MD who said it was an;
Immediately following vaccine administration patient claimed had throat closing but upon further questioning, patient had a tickly throat and patient claimed tongue felt enlarged.  Gave patient 10ml of children's benadryl (25mg) and patient felt better.  Waited in store 45 minutes following vaccine but symptoms disappeared 10 minutes following shot.  Patient left pharmacy feeling fine with wife who was home with him all day to monitor symptoms. Told patient to use benadryl throughout day.