chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is an spontaneous report from a contactable physician. This physician reported about an 11-month old female patient who received the third dose of PREVNAR 13 on an unknown date. Relevant medical history and relevant concomitant medications were unknown. It was reported that on an unknown date, the patient experienced septic 19 A hip infection. On an unknown date a culture grew S Pneumoniae 19A. Other laboratory data was unknown. Relevant therapeutic measures taken in response to the event were unknown. At the time of report the clinical outcome of the reported event was unknown.
Information has been received from a physician concerning a 9 year old white female with a penicillin allergy who was vaccinated IM in the left arm with a total of 5 doses of hepatitis B virus vaccine (lot # 647487/1240N), 2 doses were given in 2003, and 3 more given in July 2004, August 2004, and last week, on 1/17/05 at 9:15 AM. It was noted that there was no illness at the time of vaccination. The physician reported that post vaccination, the child is experiencing a high fever of 103. The patient was treated with acetaminophen and ibuprofen. The patient's status was reported as not recovered. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information from a physician indicated that a previous chest x-ray from 12/10/04 was unavailable for direct comparison, but the report was reviewed. The previous study described a left upper lobe pneumonia. On 1/18/05, the patient experienced a prolonged febrile illness. It was reported that the patient was admitted to the hospital and the work up showed the illness to be secondary to mononucleosis. On 1/21/05, a chest x-ray showed that the lungs were clear. Pulmonary vasculature was normal and the heart was not enlarged. The cardiothymic silhouette was not enlarged. The patient's bones were unremarkable. The impression was reported as a normal chest. The patient's white blood cell count was increased, but left shifted. Her intake was decreased and she was possibly dehydrated. The patient was prescribed azithromycin 200mg, 5ml, PO, qd for 1 day and then 4ml, PO qd, for 4 days. It was reported that the patient required 7 days of hospitalization. The patient's recovery status was reported as unknown. Additional information has been requested.
Flu shot 10am. Lunch 12 n. Sore arm/injection site 2 PM. Nausea, emesis, nasal congestion, scratchy throat about 3-330. Diphenhydramine 50mg po at 345 pm.
administered 6 month-4year ( maroon cap) pfizer bivalent as 1st dose vaccine.  provider spoke with mother in clinic yesterday. no apparent allergic reactions to vaccine
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 74-year-old female patient who received SHINGRIX (batch number L9CS4, expiry date 22nd February 2021) for prophylaxis. On 12th November 2018, the patient received the 2nd dose of SHINGRIX (subcutaneous). On 12th November 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In November 2018, the patient experienced injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain, injection site erythema and intramuscular formulation administered by other route were unknown. It was unknown if the reporter considered the injection site pain and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The patient was given the 2nd dose of the SHINGRIX series subcutaneously, which led to inappropriate route of vaccination. The patient experienced soreness at the injection site, pain, and redness. The reporter gave consent to follow up.
About a week after I got the first dose, I began feeling weak, hands started shaking, heart palpitations, short of breath on any exertion. On May 13th, I went in to urgent care. When I said I was short of breath they dosed me with albuterol. My heart rate shot up to 140 and I had a heart attack. I was hospitalized. Blood test showed extreme hyperthyroid condition, later diagnosed as Graves Disease. I am now under treatment for Graves Disease.  Since Graves is an autoimmune disease, I suggested to my endocrinologist that the Covid shot and then the hyperthyroid might be more than coincidental. He didn't disagree.
Information was received from a registered nurse regarding a 46 year old female patient, who on 18-OCT-2013 was vaccinated with M-M-R II, Albumin status HSA, lot #670210/0447AA, expiration date 28-MAR-2013, 0.5 ml, intramuscular. The patient received an expired of M-M-R II on 18-OCT-2013. No adverse effect reported. Additional information has been requested.
Pt was given multiple vaccines as part of her WCC; she began to have reaction sxs this morning 9/25/19 , which started as what FOC describes as a "bug bite," but then progressed to include a large area of spreadig redness, significant swelling, and itching. Pt does not c/o pain, and has not had fevers or discharge from the area, though she has seemed a bit tired. No n/v, anorexia, malaise, paresthesia, or weakness of the leg. # Vaccines adverse reaction  (T50.Z95A): Consistent with a localized (though moderately/severe) reaction; not concerning for infection or anaphylaxis. Start with topical steroids; recommended close f/u friday which MOC will call to schedule. May consider oral steroids if not improving dt the degree of swelling. Will report to VAERS, close monitoring discussed. Plan printed and provided to patient: PRESCRIBE: triamcinolone 0.1% topical cream, Apply to affected area 2 times a day, # 100, RF: 0. (Transmitted by PA-C) The injection given in the left thigh was Kinrix, which includes DTap and Polio- these are both vaccines that she's had 3 ad 4 times prior respectively, so I am suspecting this is a localized reaction to carrier substances present in the specific Kinrix formulation of the vaccine, rather than a reaction to the specific polio or dtap components. She is finished with both of these series, and won't require another Dtap- (though she will eventually need a Tdap). Recommend a topical steroid cream as prescribed, with close monitoring for worsening problems, such as swelling of lips, tongue, or face, trouble breathing, coughing, or wheezing- which would warrant urgent follow up or ER visit. Otherwise we will report this reaction to the manufacturer and agency.
Sore neck and shoulders, low grade fever, headache lasted for 1.5 days
This spontaneous report was received from a physician concerning a 22 year old female patient. The patient's concurrent conditions included multiple sclerosis diagnosed on an unspecified date that at the time of reporting seemed somewhat stable. Her drug reactions/allergies included nickel rash under allergies. On an unspecified date in 1996 at 13 months of age, the patient was vaccinated with the first dose of VARIVAX as prophylaxis, and on an unspecified date in 2008 at 13 years of age she received the second dose of VARIVAX as prophylaxis (Strength, doses, route of administration, lot numbers and expiration dates were not reported). Other suspect therapies included gabapentin (strength, dose, frequency, route and indication were not provided) started on an unspecified date and interferon beta (strength, dose, route and indication were  nor provided) weekly, started possibly in August 2015. On an unspecified date, the patient experienced left trochlear nerve palsy (IVth nerve paralysis) and was hospitalized on an unknown date in 2015. On an unspecified date in May 2017, the patient had an antibody testing completed by "commercial assay" and the results showed varicella titer as negative at 0.8 (units not provided). It was unknown if treatment was given for the events. The patient was followed by an unspecified neurologist who was interested in an additional dose of VARIVAX but it was not administered yet. The physician also stated that presently the patient was considered to be "otherwise fine". The outcome of IVth nerve paralysis and antibody test negative was unknown. The reporter did not provide the causality between the events and VARIVAX. Upon internal review, the event IVth nerve paralysis was determined to be medically significant. Additional information has been requested.
Swelling redness at injection site left thigh- site of DPT injection. Consistent with cellulitis. Treated with oral antibiotics with resolution
increase shortness of breath and pt tried putting on trilegy machine. He tried doing this two days in a row and didn't relieve his SOB, so pt went to ER and they diagnosed him with influenza B. Pt had increased weakness and had trouble with ambulation.
Patient was given ProQuad for second dose of MMR and is out of the recommended age range for this vaccine. She also received VZV vaccine at the same visit so received 2 doses of VZV vaccine on the same day.
her arm(site of Covid vaccine)was itching; raised blisters and welps over her upper arm near the vaccine injection site; raised blisters and welps over her upper arm near the vaccine injection site; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Amgen. This non-serious solicited report was reported to Amgen on 21/APR/2021 by a consumer from a commercial program.   A 59-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, administrated in arm on 01Apr2021 (age at the time of vaccination 59-years-old), as a single dose for COVID-19 immunization. The patient's medical history included Rheumatoid arthritis. The patient's concomitant medications included Etanercept (Enbrel) 50 mg weekly, from 01Mar2021 to 07Apr2021, for Rheumatoid arthritis. On an unspecified date Apr2021, the patient experienced her arm (site of COVID-19 Vaccine) was itching, and raised blisters and welps over her upper arm near the vaccine injection site. Treatment for the event injection site urticaria included Benadryl (diphenhydramine hydrochloride), Tylenol (paracetamol). Caller stated, on 01/MAR/2021, the patient took her first dose of Enbrel and noticed no reaction and was fine; second dose was also fine. On an unknown date in MAR/2021, the patient took her third dose of Enbrel and four days after the injection she developed a large, red welp five inch in diameter on her thigh. On an unknown date in 2021, the patient took fifth dose of Enbrel and the patient's reactions were coming sooner, this time within in two days and same giant welp. The outcome for all the events was unknown.  No follow-up attempts are possible. No further information is expected.
I also felt dizziness in June 2021 without any noticeable reasons; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 25Mar2021 as dose 2, single (Lot number: ER8727) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 04Mar2021, when the patient was 66-year-old, for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset Jun2021, 1 day after the suspect product(s) administration, outcome "unknown", described as "I also felt dizziness in June 2021 without any noticeable reasons". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient also felt dizziness in Jun2021 without any noticeable reasons. Patient believe this was the start-up of Pfizer vaccine side effects.  Follow-up attempts are completed. No further information is expected.
Within 5-10 minutes (actual time not recorded)after receiving ACEL DPT #2, HIB #2, IPV/OPV #2, 4 month old patient exhibited a severe shaking, convulsion-like reaction to immunizations.  Full body convulsions lasted approximately 30 seconds.  Physician documented episode but never completed a VAERS.
fine on day of for both shots but  has had more painful periods/ovulation cycles since vaccination and as of july 28 have developed seizures and Meniere's disease. unsure if it is all related but the menstrual/ovulation cycles have been more painful and nauseating than usual for the past 3 cycles (amount after vaccination to today)
She still got a bad case of flu; Initial information was received on 17-NOV-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a female patient (age unspecified) who still got a bad case of flu (Influenza), when received vaccine INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, patient developed a non-serious she still got a bad case of flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.   No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Right eyelid started itching, turning red and swelling along with rash on neck within 30 mins of receiving vaccine.  Fever, Body Aches
Patient come in today for  a boostrix shot stating we didnt have the shot on friday. She was already rung out on friday and made an appt for today. After i administered the vaccine, the patient asked about her third vaccine paperwork. She now stated she received two shots on friday and got the t-dap and covid vaccine, and actually needed the hepatitis b vaccine.  So the patient received two doses of the t-dap vaccine, one on friday 6/9/23 and today 6/12/23.  she will follow up with us if she experiences any side effects
Patient received ZOSTAVAX SQ on 5/9/16 - continued redness swelling and pain around injection site.
Pt received a vaccination from an expired vial of Hep B. (exp date was 2-2-09). Parents were advised to revaccinate the child. No adverse reactions have been reported
positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable pharmacist received via the medical information team. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date in Apr2021, the patient tested positive for COVID-19. The reporter questioned if there was a specific amount of time the patient had to wait before getting the second dose. The clinical outcome of positive COVID-19 test was unknown.   Information on batch number has been requested; Sender's Comments: Based on available information, a possible contributory role of the subject product,  BNT162B2 vaccine, cannot be excluded for the reported events of COVID-19 and suspected LOE.   There is limited information provided in this report.  This case will be reassessed once additional information is available. 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 agency, as appropriate.
Vaccine or Moderna arm appeared on day 2 and has grown larger. Condition still on going. I was reading this should be reported because it?s rare. I took Moderna for my first two shots but nothing out of the ordinary in side effects. The booster (3rd shot) there is a large rash of sorts near the injection site about an inch in diameter. The muscle underneath is very hard but sore.
patient was dizzy, and sweating and very flushed daughter is a nurse and picked him up for evaluation
Rash covering the torso, front and back. Not noticed until 6/5/21; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 12-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0191) via an unspecified route of administration, administered in left arm on 02Jun2021 at 09:45 AM, as DOSE 2, SINGLE (at the age of 12-year-old) for COVID-19 immunization. The patient medical history reported as none. The concomitant medications were not reported. Patient had no known allergies. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0172) via an unspecified route of administration in left arm on 12May2021 at 12:00 PM, as DOSE 1, SINGLE (at the age of 12 years-old) for COVID-19 immunization. No other vaccine in four weeks. No covid prior vaccination and not tested for covid post vaccination. The patient experienced rash covering the torso, front and back, not noticed until 6/5/21 on 05Jun2021. No treatment received for the events. The outcome of the event was resolving at the time of this report.   Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant, concerning multiple patients of unknown ages and genders. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of PROQUAD, lot #N010865, expiration date 01-OCT-2018, albumin status of recombinant human albumin (rHA) (strength, dose, frequency and route of administration were not reported) and with improperly stored doses of VARIVAX, lot #M000997, expiration date 07-JAN-2018 (strength, dose, frequency and route of administration were not reported) for prophylaxis. The vaccines were reconstituted with a properly stored sterile diluent (lot # and expiration date were not reported). The temperature excursion was reported as 15 °F to 46 °F (23.4°F) for a time frame of 2 hours and 57 minutes. Previous temperature excursion was reported as 6 °F to 14 °F (13.4 °F) for 2 hours. Digital data logger was involved to capture the temperature excursions. No product quality complaint (PQC) was involved. Follow-up information was received on 24-JUL-2018. Additional information has been requested. This is non-valid report due to lack of patient identifiers. Follow-up information was received on 24-JUL-2018 from the medical assistant who provided patient identifiers for the reported event. The patient was a 4-year-old male child who on 27-JUN-2018 was vaccinated with improperly stored dose of PROQUAD lot #N010865 with the expiration date of 01-OCT-2018. At the time of the excursion, the vaccine was deemed stable. No adverse event was reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA013102: US-009507513-1808USA001953: US-009507513-1807USA012551: US-009507513-1807USA012552: US-009507513-1807USA012553: US-009507513-1807USA012555.
Severe sudden onset of croup. Racemic epi neb give, decadron in office.  Transferred by ambulance to hospital for overnight observation.
Patient was admitted to hospital on 04/01/04 with diagnosis of orbital cellulitis, mucopurulent blepharoconjunctivitis possibly secondary to self-inoculation of vaccinia.  He received his primary smallpox vaccination on 03/23/04, along with typhoid vaccination.  He attended the SPV briefing on that date and received educational brochure.  He reports no complaints on the date of vaccination.  His smallpox vaccination site has followed the normal course of healing.  His only complaint has been that the site was itchy and red.  No chest pain shortness of breath.  Few discrete papules on bilateral papules on bilateral upper extremities, but patient states this is baseline for him.  1 pustule on forehead-? acne.   On 03/31/04 (day 8 post-vaccination) he was at the range and reports that sand blew into his left eye.  By the time he arrived back to work, the eye had become itchy and red.  The next morning upon awakening, his left eyelid was matted together.  He describes his left eye as painful, burning, and itching.  Since awakening, clear tears have been running out of his eye.  His vision is blurry in his left eye and he complains of diplopia.  He does not wear contacts or glasses.  When he looks at a bright light, he experiences intense pain.  If he closes his left eye and looks at light, he does not experience any pain.  No other complaints except for a mild headache.  He reports that he has followed all precautions after receipt of smallpox vaccination. He wore a long-sleeve shirt during the day but did not keep a bandage over the site.  When he arrived home, he would apply a bandaid over the site and wear a short-sleeve shirt.  He reports that he washed his hands frequently, kept his laundry separate, did not share linens, and always washed his hands after touching the site.  He does state that the site was extremely pruritic and is afraid that he might have scratched the site at night and ?rubbed his eye.  An emergent ophthalmology consult was obtained, and the service member was admitted with a diagnosis of periorbital cellulitis under the service of family practice with ophthalmology consulted.  He was started on empiric antibiotic coverage with Cefuroxime 1.5 gm IV q 8 hours.  VIG has been requested and is being shipped.  No evidence of vaccinia keratitis.  Viral and bacterial cultures are pending.  CT scan shows evidence of pre-septal cellulitis with NO post-septal involvement.  Nurse follow up on 08/19/04 states: "Keratitis."
Patient got the PNEUMOVAX 23 in the left arm on 8/19/18. She called on 8/20/18 to pharmacy describing that her arm is swollen, red, and hot to the touch. She went to urgent care on 8/20/18.  Patient stated that the doctor gave the patient 9 pills of prednisone and discharge the patient with bactrim and a medrol dose pak prescriptions to get at the pharmacy. I followed up with the patient on 8/21/18. She is okay.
HEADACHE; SICK TO STOMACH; BODY HURT/COULD NOT MOVE/FELT LIKE A SEMI HIT 5 TIMES; START TO THROW UP; SICK FOR 2 DAYS; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  On APR-2021, the subject experienced sick for 2 days. On 09-APR-2021, the subject experienced body hurt/could not move/felt like a semi hit 5 times. On 09-APR-2021, the subject experienced start to throw up. On 09-APR-2021, the subject experienced sick to stomach. On 10-APR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body hurt/could not move/felt like a semi hit 5 times, had not recovered from sick to stomach, and the outcome of headache, sick for 2 days and start to throw up was not reported. This report was non-serious.
Tdap given Lt deltoid 6/20/09 - no previous reaction reported - over 10 yrs on tetanus. Called 6/24/09 - Pt reports lightheadedness, fever x2 days - up to 101 degrees and 3" square red/hot site on arm. Has resolved now
Swelling and redness at site, fever, chills, headache,  bodyaches, body sweats, joint pain , diarrhea.