chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a healthcare professional, refers to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The healthcare professional informed that on an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB, lot # J014855 expiration date: 16-APR-2016 and lot # L016959, expiration date: 12-MAR-2018 (dosage and route were not provided). Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
PNEUMONIA; The spontaneous report was received from a pharmacist, referring to a 68-year-old female patient, via PFIZER. The patient's concurrent conditions, medical history, concomitant therapies and allergies were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) (dose, route, lot number, expiration date and anatomical location were not reported) for prophylaxis. On an unknown date, the patient was vaccinated with pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) (dose, route, lot number, expiration date and anatomical location were not reported) for prophylaxis.  On an unknown date in September 2022 (reported as 5 months ago), the patient the patient was hospitalized due to pneumonia and was in the hospital "quite awhile" due to the pneumonia. The patient did not have been administered pneumococcal vaccine conj 20v (crm197) (PREVNAR 20). The patient was wondering if there was a time fame from having pneumonia before they can go with the pneumococcal vaccine conj 20v (crm197) (PREVNAR 20). The patient was wondering if she received a pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX 23) shot in their 50's be eligible to get a shot of pneumococcal vaccine conj 20v (crm197) (PREVNAR 20). The outcome of pneumonia was not provided. The causality between all suspect therapies and pneumonia was not provided.  Upon internal review, the event of pneumonia was determined to be medically significant.
Patient received vaccine total 5, DTaP, HiB, PCV-13, IPV, Influenza at the MD clinic. At home patient fell asleep for 2hrs, then woke up crying, irritable, mother noticed patient became stiff and limp after, eyes wanting to roll back.
Lot 157003 Given at facility - It already felt weird going in because I noticed it was placed too high, but could not stop it. I hoped it would be okay but within days, I could not move my arm and was in constant pain. Treatment with corticosteroid injection (had reactions of 2-3 word dyspnea, palpitation, nausea, three pillow orthopnea) and pain returned within two months. MRI revealed multiple cysts formed with dystrophy of all surrounding shoulder muscles. Received PT but still living with cysts and occasional flare of inflammation with related sever shooting pain and immobility.
Patient (101 yr old) informed the long term care facility and the pharmacy administering the vaccination that she had not been previously vaccinated.  The Moderna vaccine was administered on 5/13/2021 (lot#022C21A).  Upon reporting it was discovered that she had received Pfizer covid-19 vaccine (lot#EN5318) on 2/02/2021. informed immediately and enhanced monitoring was put into place within 4 hours of the vaccination. I am not aware of any adverse effect at this time, however I am reporting as recommended on the CDC website for mixed series administration.
RAPID HEARTBEAT; SORE ARM; HEADACHE; FEVER; This spontaneous report received from a patient concerned a 20 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 02-JUL-2021 for prophylactic vaccination. No concomitant medications were reported. On JUL-2021, the subject experienced rapid heartbeat. On JUL-2021, the subject experienced sore arm. On JUL-2021, the subject experienced headache. On JUL-2021, the subject experienced fever. Laboratory data included: Body temperature (NR: not provided) not reported, and Heart rate (NR: not provided) rapid. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heartbeat, headache, and fever on JUL-2021, and had not recovered from sore arm. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case assessed as non-serious.
4 hrs after receiving Pneumovax inj pt developed redness swelling and welts on her right arm.
Pt recvd 1st dose of Hep B vax in JAN91 & 2nd dose of vax FEB91; It was noted that pts fingernails turned yellow & pt exp pain in hand; It was felt that the pt's condition was related to medi-fast;
outbreaks of a painful blistering rash, along with nerve pain that remained after the rash subsided; outbreaks of a painful blistering rash, along with nerve pain that remained after the rash subsided along with nerve pain that remained after the rash subsided; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unspecified age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, the patient suffered severe outbreaks of a painful blistering rash, along with nerve pain that remained after the rash subsided along with nerve pain that remained after the rash subsided. As a result of these symptoms, the patient presented to a medical provider and she was diagnosed with Herpes Zoster and Postherpetic Neuralgia (dates un specified). Thereafter, the pt. had continued to suffer the effects of herpes zoster and post herpetic neuralgia. As a result, she had suffered and would continue -to suffer significant medical: expenses, pain and suffering, and other damages. The outcome of the events was considered not recovered/not resolved. The events were considered related to zoster vaccine live (ZOSTAVAX).
Rash on right arm of injection from elbow to knuckles. Intense itching. A few days later, pain. Then rash developed on right side of face & neck. Intense itching. Then rash developed on left side of face & neck. Then intense itching.
pt devel pancreatitis w/in 24hrs p/vax vax;no further details are known as of the date of this report;
This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of ZOSTAVAX which had Lot number  M019646 with expiry date on 18-JUL-2017 and lot # M038864 with expiry date on 12-DEC-2017 (strength and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccines were exposed to temperature of > -10 but <8 Centigrade range for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested. ; Sender's Comments: US-009507513-1703USA008046: US-009507513-1703USA008048: US-009507513-1703USA008049: US-009507513-1703USA008050: US-009507513-1703USA008051: US-009507513-1703USA008052: US-009507513-1703USA001827:
Patient complained that injection site swollen and red. Suggested checking with Dr. Dr stated no cellulitis recommended warm compresses.
Several days after vaccine administration patient experienced severe soreness. After that a rash developed around the administration site covering half of the patient's deltoid. Swelling other area has also occurred. Patient will be seeing PCP.
Fever and chills following PNEUMOVAX. Redness and swelling around injection site and temperature as high as 103 with some occasional cough and shortness of breath. He felt weak when he got up and episode of sweating and blurred vision followed by diarrhea. Explained need for epinephrine if symptoms worsen advised go to Emergency Room, advised loratadine 10 mg BIG with PM hydroxyzine if needed. Continue ibuprofen.
the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Aug-2021, the patient experienced COVID-19 (the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021). At the time of the report, COVID-19 (the patient said he had a mild case of covid/ took the first dose on 26July2021 , and tested positive for Covid on 2August2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No treatment medications were provided.
been experiencing excruciating pain on the opposite side of the vaccination site; there is a bit of swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (been experiencing excruciating pain on the opposite side of the vaccination site) and VACCINATION SITE SWELLING (there is a bit of swelling) 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 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (been experiencing excruciating pain on the opposite side of the vaccination site) and VACCINATION SITE SWELLING (there is a bit of swelling). At the time of the report, PAIN IN EXTREMITY (been experiencing excruciating pain on the opposite side of the vaccination site) and VACCINATION SITE SWELLING (there is a bit of swelling) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
10:51 metallic taste in mouth 10:58 tongue numbness, not able to feel tongue and on roof of mouth 11:08 hr 100-113 resp 20 bp 124/72 11:10 progressibly more difficulty when swallowing, lungs cta, individual was anxious 11:12 transferred to ED via wheelchair
Syncope. Woke up (9/14/11) got out of bed turned off alarm felt himself fall to floor. Found himself on floor, eye blurry, had banged (L) forehead and shoulder. Then went out of room, mom saw him, he said he had fallen, after sitting for a while felt better, went to school but had a headache and mild nausea during the day. No vomiting. On 9/13/11 pt received FLUMIST, HPV, varicella, Tdap and MCV. Happened approx 18 hours after injection.
RHINORRHEA AND FEVER FOR 2 DAYS PRIOR TO PRESENTATION. MAXIMUM TEMP 101.3F.  RIGHT OTITIS MEDIA FOUND ON EXAMINATION AND WAS PRESCRIBED HIGH-DOSE AMOXICILLN ON 10/23/2009.
pt recvd vax & had muscle spams of arms & legs the evening vax given; eyes were big & parents took pt to ER dept states on way to ER began having small sz & jerky all over; t99 R;
08/15/97 vax received. On 09/23/99 the pt developed 12 lesions of varicella on his neck, back, abdomen and legs. He was presented to a physician with symptoms and was afebrile. Therapy with Aveeno bath was recommended for itching. Lesions scabbed within 5 days and subsequently subsided.
Chills, Fever, Diahrrea and headache for 3 days.  Took Tylenol which made the fever and chills better.
Patient says she started feeling nauseous the next day and was tired for a couple days. Then 1 week after injection developed a red blotchy rash all over injection site down to elbow (was still visible when pt presented to pharmacy on 8/30). Also stated she has a connective tissue disorder that has been flaring up since injection and has had increased stiffness in hands.
Two people tested positive for COVID-19 after the administration of that first dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Two people tested positive for COVID-19 after the administration of that first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No recorded medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Two people tested positive for COVID-19 after the administration of that first dose). At the time of the report, SARS-COV-2 TEST POSITIVE (Two people tested positive for COVID-19 after the administration of that first dose) outcome was unknown. Infection control nurse at hospital mentioned how she was giving the Moderna COVID-19 vaccine for about two weeks and two people tested positive for COVID-19 after the administration of that first dose. She was wondering if they can they take the second dose and when. She also mentioned that the CDC mentions that they should not administer that second dose if a patient had a previous or known allergic reaction to any of the ingredients in the Moderna COVID-19 vaccine. She stated that one of the doctors in the hospital wants to medicate a patient before and take all necessary precautions when vaccinating this person with the Moderna COVID-19 vaccine and if it is okay. She did not want to give me any information about the lack of efficacy in those two patients who tested positive for COVID-19 after taking the first dose of the Moderna COVID-19 vaccine but did give me the lot number. Consent for safety to follow-up with her- Yes YNS8Jan2021 Agent spoke from SRD: Contraindications And Warnings And Precautions I told her I cannot decide whether the doctor should do that or not but instead read her what Moderna says about it and gave her the CDC website.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test positive: positive (Positive) Positive.     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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: This case concerns a patient of unknown age and gender with a nonserious unexpected event of SARS-CoV-2 test positive. Event onset with unknown latency after first dose mRNA-1273. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
severe rxn screaming, trouble breathing, eyes looked funny, inconsolable, swollen hands & feet, rash on buttocks, red all over body;tx DPH;
Caller reports vaccine was administered after experiencing temperature excursion/ Names of vaccines involved (including lot/exp) VARIVAX  Lot: U02505 / Exp date: 8/13/2022/ Temperature -11.6C/T ime frame  0 hour 30 minutes; No additional AE details; This spontaneous report has been received from an unspecified reporter referring to a patient (gender not provided) who was 1-year-old at the time of reporting.   The patient's concomitant medications included sterile diluent. The patient's pertinent medical history, concurrent conditions and drug reactions or allergies were not provided.   On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) administered for prophylaxis, that underwent a temperature excursion of -11.6 Celsius grades in 30 minutes (product storage error); lot number U02505 is an invalid lot number for varicella virus vaccine live (Oka/Merck) (VARIVAX); expiration date on 13-AUG-2023 (strength, dose, frequency, and route of administration were not reported). No additional adverse events were reported.
Headache and itching at the injection site. Redness and swelling appears to be about 4 inches by 1 & 1/2 inch area with center to be about 1 inch in diameter with darker red in color. Pt c/o area to be painful to touch and had mild chest tightness; which all symptoms are relieved by taking 2 caps of Benadryl 25mg every 4.5-5 hours.  PT took med first on 5/6/12 8:00 AM then at 2:00 PM and at 9:00 PM. Pt also took Allegra 180mg 1 tablet once around 2pm which she takes in daily basis. PT comes into pharmacy with larger swelling but faded redness in color at injection site (4.5 inches by 2.5 inches in size of rash at injection site).  Pt still c/o of itchness, painful to touch, warm to touch and headache and mild chest tightness which all are relived by 2 cps of Benadryl 25mg q 4.5-5 hours and Allegra 180 mg qd (pt took 2 Benadryl on 5/7/12 at 7:00 AM and at 12:30 pm today.  Pt does not feel she needs to seek medical help.
pt recvd vax 15MAY95 & w/in 1 wk pt devel a papular rash on the back & @ the inj site;seen by MD;no treatment initiated;resolving;pt had a rash following Tetramune @ 2mos
5 yo who presented to clinic 3 days post vaccines in Rt arm, developed redness, warmth & swelling to Rt upper extremities - no fever no pain intact neuro/sensory TX with KEFLEX
lightheadedness and malaise developing day of immunization, wwith nausea at bedtime. awakened in the morning, had 2 episodes of vomiting, and one of diarrhea
Patient reports severe pain at site of injection, and the next evening had numbness and tingling in left side of neck and inside the ear.  The ear continues to feel numb and tingles inside, the neck has now gotten better.
Pt. called and stated her arm was sore from the flu shot she received on 9/28/11. She called on 10/10 and 10/13.
Patient had seizure about 45 minutes after receiving Covid 19 vaccine.  Dr at ER confirmed this seizure was not related to Covid vaccine.  Patient didn't take Depakote for 2 days.  His Depakote level was low.  Patient has history of brain tumor and seizure.
ED to Hosp-Admission  Discharged 10/26/2021 - 10/29/2021 (3 days)   COVID-19 HPI: This is a very pleasant 92-year-old male with a past medical history of chronic systolic congestive heart failure, ischemic cardiomyopathy, ICD placement in 2013, coronary artery disease with CABG 1999/subsequent stenting, diabetes mellitus, and atrial fibrillation on anticoagulation who presented to hospital with shortness of breath found to have acute hypoxic respiratory insufficiency in the setting of acute on chronic systolic congestive heart failure likely provoked by viral illness.  Patient tested positive for COVID-19 however has mild symptoms.   Hospital Course: Patient was hospitalized and underwent diuresis and supplemental oxygen.  Ultimately, he was able to be weaned off of oxygen and did not require any home O2 at discharge.   In regards to COVID-19, patient remains mildly symptomatic from this and has cold symptoms without any signs of Covid pneumonia.  At this time, as he was able to be weaned off oxygen due to treatment of CHF, I inclined to think that while the COVID-19 probably exacerbated his CHF, it is not significantly active and does not warrant any further treatment.  Additionally, his transaminases are mildly elevated and that could be due to viral infection.  Liver ultrasound in hospital was unremarkable and his LFTs have stabilized.  At this point, I would repeat these in 5 days to ensure that they are improving.
On 11/15/2016 pt received PREVNAR 13 vaccination. On 11/27/16 pt returned to say her left arm has been painful every since.
Developed low grade fever early 5:00 am 6/07 when came into our bedroom. Continued thru day. We went for walk 6/07 afternoon complained she was too hot (101.5). Came in for drink. She collapsed onto floor. Had (unconscious) seizure w/ jerking for approx 2-3 min. Rash on day 3.
Information has been received from a certified medical assistant concerning a 63 year old female who on Aug 25 2004, was vaccinated intramuscularly in the left arm with a first dose of pneumococcal 23v polysaccharide vaccine (lot 646078/0257N). it was reported that on Aug 26 2004, the patient developed a 1.5 inch diameter, approximately 3-4 cm, red site reaction several hours after receiving vaccination. The patient was treated with acetaminophen (Tylenol). The patient iced the site for the afternoon. The patient ws called and was fine the next day, the reaction was totally resolved within 72 hours. No additional information is expected.
24 hours after injection had local area of induration and erythema over next few days and ecchymotic area developed in center with surrounding erythema. Warm compresses to area advised.
Pain, redness and swelling on right arm. Rt eye swelling. Rt leg pain, rt cald and rt thigh aches.
Red, swollen, painfull around injection site. Lasted about 2 weeks. Resolved now.
Inconsolable screaming, arching back, convulsing, red thigh (where injection was made), hardened spot, very warm thigh.
Itchy; Swollen lymph nodes and neck; Swollen lymph nodes and neck; Swollen at the site, up the arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy), SWELLING (Swollen lymph nodes and neck), LYMPHADENOPATHY (Swollen lymph nodes and neck) and VACCINATION SITE SWELLING (Swollen at the site, up the arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Shingles. Concomitant products included HYDROCHLOROTHIAZIDE.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (Itchy), SWELLING (Swollen lymph nodes and neck) and LYMPHADENOPATHY (Swollen lymph nodes and neck). 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Swollen at the site, up the arm). At the time of the report, PRURITUS (Itchy), SWELLING (Swollen lymph nodes and neck), LYMPHADENOPATHY (Swollen lymph nodes and neck) and VACCINATION SITE SWELLING (Swollen at the site, up the arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information included as Rubbing alcohol on the injection site
12/29 Injection site soreness 12/30 Fatigue, SOB, cough, muscle aches, mental slowness; increased secretions with cough
3 days after immunization client has increased difficulty with breathing and has chickenpox-like areas to skin without itching.