chrisvoncsefalvay/vaers-outcomes huggingface dataset:
got the shots, got shingles; shingles; Not feeling so good; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling unwell. On an unknown date, the outcome of the vaccination failure, shingles and feeling unwell were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and feeling unwell to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she got the Shingles vaccine a couple years ago before reporting date. The patient stated he/she got shingles a week ago before reporting date. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This case was reported by a other health professional via call center representative and described the occurrence of paralysis in a 43-year-old female patient who received BEXSERO (batch number 148901, expiry date 1st September 2016). Concomitant products included FLUARIX. On 15th October 2015, the patient received the 1st dose of BEXSERO. On 15th October 2015, 12 hrs after receiving BEXSERO, the patient experienced extensive swelling of vaccinated limb, injection site induration and injection site pain. On 3rd November 2015, the patient experienced paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the paralysis, extensive swelling of vaccinated limb, injection site induration and injection site pain were not recovered/not resolved. The reporter considered the paralysis to be possibly related to BEXSERO. The reporter considered the extensive swelling of vaccinated limb, injection site induration and injection site pain to be probably related to BEXSERO. Additional details were provided as follows: The reason patient was given BEXSERO was due to splenectomy. The patient also received FLUARIX on the same day but in separate arm. The health care professional reported that the patient received BEXSERO and within 12 hours the patient developed pain, swelling and an induration at the injection site. The swelling and pain increased to axillary lymph nodes. Also two and half weeks later patient at the time of reporting had paralysis of the pinky finger in arm where shot was given.
Case completed primary Covid vaccine series in March 2021, then was  hospitalized in September and October 2021 for Covid.  Hospitalized at Hospital, discharging doctor: MD Hospitalist.    Discharge after hospitalization 9/23-9/27/21: Patient is a 69-year-old gentleman with remote history of colon cancer with remaining ostomy, former smoker, documented history of COPD though I do not see any PFTs on file who presented to the emergency department with 2 weeks of generalized weakness, weight loss, cough, night sweats, shortness of breath. He was positive for COVID-19 and met sepsis criteria. CT scan of his chest was notable for a consolidation throughout the right lower lobe with questionable 9.5 x 6.3 cm mass in the superior portion. Also a right hilar soft tissue attenuation likely causing narrowing of the right middle and lower lobe bronchus. He was initially requiring 3 to 4 L of oxygen. And was treated for postobstructive pneumonia with ceftriaxone, azithromycin, Flagyl. He was also started on on Decadron because of his positive Covid test. The patient is vaccinated however ID felt that there were also some imaging findings to suggest active Covid pneumonia here and perhaps that was playing a role in his hypoxemia. Case was discussed with on-call pulmonary medicine who recommended treatment of his acute infections and have the patient follow-up as an outpatient for further evaluation of his lung mass. ID was consulted and recommended a prolonged course of antibiotics given some concern for possible lung abscess formation. He was discharged on 3 weeks of Augmentin and with the plan that he will be seen in ID clinic before antibiotic stop date to determine whether he will need a longer course. He was discharged on 4 L of oxygen. . The patient's oxygenation remained stable and he felt significantly better at time of discharge and ready to go home. He also had 1 set of blood cultures that were growing 2 different organisms. This was thought to most likely be a contaminant however repeat blood cultures were drawn to ensure there is no persistent bacteremia. These will be monitored after discharge  DIscharge summary after hospitalized 10/4-10/7/2021: Briefly, this is a 69 y.o. male with PMH significant for recent COVID and Right lung mass with post-obstructive pneumonia on home o2 and augmentin who presented with worsening right lower anterior chest pain. Found to have completely collapsed RLL and enlarging mass on repeat imaging. Changed to unasyn while admitted and had CT-guided biopsy 10/4 that showed probable adeno of colonic origin with history of colon/rectal cancer in 2012. Pain was eventually controlled with every 6 hr oxycodone, and Dr did not feel benefit of XRT was worth risk as there was no specific culprit area obviously causing pain, therefore entire 11 x 7 cm mass would need irradiated. Plan to follow up with Doctor on Nov 1 to discuss palliation. Will stay on augmentin to prevent relapse as doubt RLL will ever be open again unless responds to palliation, and have follow-up with clinic.
Swelling, redness, and pain of L shoulder where Hep A and Menactra administered.
This is a spontaneous report from a contactable consumer and from a contactable physician. A 89-year-old male patient received PREVNAR 13 (Lot/Batch H86212), on 20Nov2014 between 8 and 9 in the morning in the right arm at single dose. Patient had anaemia from Jan2015 and ongoing, ongoing hypertension for 40 or 50 years. Concomitant medication included amlodipine for blood pressure decreased from 2013 at 10 mg daily and from Nov2014 at 5 mg daily and ongoing, Vitamin D3 orally for low Vitamin D and lack of sun at 1000 units once a day from 2015 and ongoing, lisinopril for heart orally at 40 mg, 1x/day (at night) from 2010 and ongoing and atenolol for heart at 50 mg twice a day from 1990 and ongoing, garlic 1000mg and vitamin B2 50 mg. Patient specified he was taking amlodipine in the morning and that 7 days prior to the injection, he was told to cut the amlodipine down from 10 mg daily to 5 mg daily. 50-60 years before, the patient received cholera vaccine and had poisoning and body reaction as he got a big bubble. On 10Jan2015 lab tests were done with the following results: triglycerides and glucose were good and high density lipoprotein level was a little low. On 18Jan2015 patient got rash on his legs, internal itching effect on whole body, rough skin and was retaining fluid in ankle and calves. Events "rash" and "itching" were treated with Prednisone and he took BENADRYL which helped to hold down the itch a little bit. The patient visited a physician, who told him about the possibility that the retaining fluid could be caused by his blood pressure medication. Amlodipine decreased from 10 mg to 5 mg helped to decreased the fluid level a little bit. "Fluid retention" as considered serious as it led to hospitalization. Outcome for "rough skin" and "Fluid retention" was not recovered; patient recovered from the other events. The reporting physician stated that the patient mentioned he got the vaccine about 2 months before the report and then had the rash 1 month later. However the physician was not sure if it was related to the vaccine and was not aware of the reported adverse events. Follow-up (30Mar2015): New information from a contactable physician includes: causality assessment detail. Follow-up(01May2015): New information from a contactable consumer includes: concomitant, vaccine and details, seriousness. Follow-up attempts completed. No further information expected.
sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) 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. ASKU) 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 ILLNESS (sick). At the time of the report, ILLNESS (sick) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   This case contains information about patient 01 out of 04 patients. No concomitant medication was provided by reporter. Four adult  patient was impact due to Moderna COVID-19 Vaccine for Illness. Reporter assumed patient  get sick because of the vaccine . Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-738488, US-MODERNATX, INC.-MOD-2023-738489, US-MODERNATX, INC.-MOD-2023-738490 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-738489:Patinet 3 US-MODERNATX, INC.-MOD-2023-738488:Patient 2 US-MODERNATX, INC.-MOD-2023-738490:Patient 4
Patient  received Havrix (1440 adult); Patient received Havrix (1440 adult); Patient received Havrix (1440 adult); This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 18-year-old female patient who received HAV (Havrix 1440 adult) (batch number km72c, expiry date 18th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th September 2022, the patient received Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 13th September 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose, inappropriate age at vaccine administration and expired vaccine used. On an unknown date, the outcome of the overdose, inappropriate age at vaccine administration and expired vaccine used 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: 13-SEP-2022 Reporter's Comment: The reporter who stated that a patient received an expired dose of Havrix at the time of reporting.  The reporter did not consent to follow-up. Additional Supportive Information: The patient received an expired dose of Havrix at the time of reporting, which led to overdose, inappropriate age at vaccine administration and expired vaccine used.
Very itchy Rash on face, arms, leg- began day after shot and continued.  I tried taking Benadryl and using Cortizone 10 .  They were not helpful.  I saw my physician and was given  medication which effective.
11 days after vaccination I broke out in hives; had swelling in my face; feet; hands; chills.
Information has been received from a certified medical assistant concerning an adult patient (gender unknown) who on an unknown date was vaccinated (route unknown) with a dose of Pneumovax 23 (Lot # 651319/1007P). After receiving the vaccine, the patient developed cellulitis. The outcome of the patient's experience was not reported. Unspecified medical attention was sought. No product complaint was involved. In follow up information, the medical assistant reported that she does not have patient information or lot number information. She reported that she can not confirm that the initial lot number reported was correct. She said "An antibiotic is sometimes ordered for a patient with cellulitis" but she does not know if the patient received an antibiotic. She has no further information to provide. Additional information is not expected.
Pt recvd HIB/OPV on 9APR91 & mom reported some episodes of falling backward; @ office visit, pt appeared fine; that evening had a generalized sz; 2 yrs earlier, was seen by neurologist for an enlarged head;
Nausea, dry heaves, extreme malaise.  This progressed to severe headache, vomiting, hypertension.  Had to be admitted to hospital to rule out aneurysm due to severity of headaches.  Had to have a MRI/MRA, CAT scan of brain, lumber puncture to rule out meningitis, brain bleed, etc.
Right arm was swollen; Tingling Sensation down to finger; Severe headache very intense; Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Right arm was swollen), PARAESTHESIA (Tingling Sensation down to finger), HEADACHE (Severe headache very intense), NAUSEA (Nausea) and VOMITING (Vomiting) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013620A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported). Concomitant products included ACETAMINOPHEN and IBUPROFEN (ADVIL 12 HOUR) for an unknown indication.   On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Right arm was swollen), PARAESTHESIA (Tingling Sensation down to finger), HEADACHE (Severe headache very intense), NAUSEA (Nausea) and VOMITING (Vomiting). At the time of the report, PERIPHERAL SWELLING (Right arm was swollen), PARAESTHESIA (Tingling Sensation down to finger), HEADACHE (Severe headache very intense), NAUSEA (Nausea) and VOMITING (Vomiting) had not resolved.      No treatment information was provided.
Vaccine administered, patient complaint of tingling hands, feet, mouth. complained of feeling warm and itchy.  Benadryl 50 mg given orally. Vital signs stable. Patient stated she felt better at 3:10 pm. discharged to home accompanied by companion.
Tested positive for Covid; Tested positive for Covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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 "unknown" and all described as "Tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Tested positive for Covid. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine (Pneumovax 23) was administered on 8/5/09, and several hours later patient reported pain at site with associated weakness of arm, nausea, vomiting, and feeling of weakness in her whole body. She was seen in the emergency department, given Vicodin for pain, and asked to follow-up with us. She saw us in the afternoon of 8/6/09, and at the time reported feeling improved, although she was sleepy from the Vicodin and still somwhat nauseated.
weakened immune system; On 05Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 26Jun2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech.; sick; bronchitis; strep throat; sore throat; thrush; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4168711-00.  A 46 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administration date 26Jun2021 (Batch/Lot number: unknown) at the age of 46 years as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for psoriasis, rheumatoid arthritis. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: 05Apr2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "weakened immune system"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "On 05Apr2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer BioNTech. On 26Jun2021, patient received 2nd dose COVID-19 Vaccine manufactured by Pfizer BioNTech."; ILLNESS (non-serious), outcome "unknown", described as "sick"; BRONCHITIS (non-serious) with onset Nov2021, outcome "unknown", described as "bronchitis"; PHARYNGITIS STREPTOCOCCAL (non-serious) with onset Jul2021, outcome "unknown", described as "strep throat"; CANDIDA INFECTION (non-serious) with onset 2021, outcome "unknown", described as "thrush"; OROPHARYNGEAL PAIN (non-serious) with onset Jun2021, outcome "unknown", described as "sore throat". The reporter's assessment of the causal relationship of the events of sick, weakened immune system, bronchitis, strep throat, thrush and sore throat was not provided with suspect product (Bnt162b2). The reporter's causality for the event(s) of sick with humira(adalimumab) was a reasonable possibility. The reporter's causality for the event(s) of weakened immune system, bronchitis, strep throat, thrush and sore throat was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events Immunodeficiency, Illness, Bronchitis, Pharyngitis streptococcal, Candida infection, and Oro-pharyngeal pain and BNT162B2.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
1130A received FLUMIST intranasally - went to daycare ate lunch vomited large amount 1x at 430 pm.
A non-serious spontaneous report of nose bleed was received by an employee in a pediatric office, concerning a five-year old female subsequent to FLUMIST. Neither medical history nor concomitant medications have been reported. The patient received FLUMIST on an unreported date. Immediately after FLUMIST administration, the patient developed nose bleed in one nostril. The bleeding was easily controlled and stopped before the patient left the pediatrician's office.
IPV give sq Rt leg 7-10-07 red area treated at clinic 7-12-07 with Keflex 250m Q10x 7 days
Site: Bruising at Injection Site-Medium, Site: Pain at Injection Site-Medium, Systemic: Patietn has brusing just below the injection site. hurts while lifting arm-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: patient has brusing at the injection site.
PATIENT FELT DIZZY AND FELL AS HE WAS WALKING OUT OF THE IMMUNIZATION ROOM. HE WAS BROUGHT BACK INTO THE IMMUNIZATION ROOM AND BLEEDING WAS STOPPED. HE STATED HE WAS FINE AND DID NOT WANT US TO FILE A CLAIM/REPORT. HE LATER CONTACTED US TO LET US KNOW HIS KNEE WAS SWOLLEN. WE FORWARDED TO OUR CLAIMS DEPARTMENT AND THEY ARE HANDLING IT FROM THERE.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 28-FEB-2019, the patient was vaccinated with an expired dose of M-M-R II (rHA), lot # M045391, expiration date 14-NOV-18 for prophylaxis (dose and route of administration were not reported) (expired product administered). The vaccine was reconstituted with Diluent MRK lot # R0006343, expiration date 01-DEC-2020. The outcome of expired product administered was not reported.
On 3/20 a rash developed on arms, hands,  top and bottom of feet which also constantly itched. This continued and on 3/27, we noticed hands and feet were starting to swell. The arms and legs began to have hives. I contacted the oncologist who advised this may be an immune system reaction advised  contact the rheumatologist. By 4/1,  blisters had developed on her feet. As well as two wounds, one on the pelvis and one under her right breast. I decided to take her to the emergency room, explained the course of reactions to the doctor. After labs returned and our consultation, the diagnosis was Urticaria. Prednisone, Benadryl and Pepcid was administered and prescribed. On 4/5 the swelling was reducing, the hives were gone plus she was no longer itching. As of 4/7 the swelling of hands and feet is now gone, the 3 blisters are still in place and have not drained. My mom feels 90% better.
Information has been received from a nurse practitioner concerning a "7 or 9 year old" female who in "the last couple of months in" approximately March of 2007 was vaccinated subcutaneously with a 0.5 mL second dose of varicella virus vaccine live (Oka/Merck). Subsequently, "in the last couple of months," in approximately March 2007, the patient developed a softball size swelling and itching at the injection site. Unspecified medical attention was sought. Subsequently, the patient recovered. There was no other information provided. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a Nurse refers to an unspecified number of patients of unknown ages and genders. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On an unknown dates the patients were vaccinated with improperly stored doses of VAQTA lot number M003011 expiration date 15-NOV-2017. Dose, the patient's frequency, anatomical location and route of administration were not provided. Temperature: 32.9 Fahrenheit degrees, time: 5 hours. Digital data logger was involved, no previous exposures and no product quality complain involved. No other suspect medications or concomitant therapies were reported. No adverse effects were reported. This is one of four reports received from the same reporter. Additional information has been requested.