chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feel tired all the time; Headache; feel sick to my stomach; do not feel good; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 01Apr2021 (Lot number: ERC733) at the age of 80 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "dizzy spells" (unspecified if ongoing). Concomitant medication(s) included: MECLIZINE [MECLOZINE HYDROCHLORIDE] taken for dizziness. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "feel tired all the time"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "feel sick to my stomach"; MALAISE (non-serious), outcome "unknown", described as "do not feel good". Therapeutic measures were taken as a result of headache.  Additional information: Patient was also taking an unspecified blood pressure medicine as a concomitant medication. Patient took Rizatriptan as a result of headache.  No follow-up attempts are possible. No further information is expected.
Patient had her first Moderna Covid Vaccine on 01/07/2021 she awoke on 01/10/2021 with pain, and stiffness in her shoulder neck and back that lasted for 5 days and then on 01/16/2021 her arm around her injection site turned very red and was itching badly, this was relieved by Benadryl and all the issues were resolved by 01/20/2021
Next day flu like sxs, 3rd day rash on base of neck, armpits, thighs-like urticaria-lasted 1 wk.Flu sx lasted 1 wk /w fever(99-100) & fatigue.
Pain and tightness in left hip and left leg. No relief when sitting, standing, walking or lying down. First appeared 24-36 hours after 1st dose of the COVID vaccine. Arm soreness 30 minutes after injection which increased and then went away by the 2nd day post vaccine. Throbbing headache that woke me from sleep less than 24 hours after vaccination. Fatigue three hours after injection in which I had to lie down and sleep. I was woken up 3.5 hours later. Felt fatigued for the following three days post vaccine.
Motion sickness without motion and vertigo lasting from June 1st through June 10th.   Affects ability to function properly at work.
Patient presented with Edema and developed CHF and Cardiomyopathy progressing to death on 08/15/2021
Received DTaP/ Prevnar and HIB 02/22. Starting within 24 hours series of startle episodes lasting 10+ seconds. Episodes progressing more prolonged. Dx as seizure disorder early March. Currently on meds: Phenobas and Topanes. The 60 day follow up received on 7/24/03 states, "this baby has an ongoing seizure disorder-having 0-5 seizures daily, comprehensive w/u so far (-)."
Varicella - Information has been received from a physician concerning a 4 year old white male with a history of exposure to varicella virus in the week of 02 May 2000 who on 04 Oct 1996 was vaccinated with the first dose of varicella virus vaccine live (unknown site) on 09 May 2000 the patient developed a mild case of chicken pox with less than 30 pox.  the reporter indicated that the patient was doing well and a full recovery was expected in 7-10 days.
Ocular migraine; This is a spontaneous report received from a contactable female consumer (patient). A 4-decade-old (30s) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered in unspecified location on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, few days after the vaccination, the patient experienced ocular migraine. The reporter assessed all events as non-serious. Caller wanted to know if ocular migraine was included among the commonly reported AEs, the caller also wanted to file a complaint due to lack of information on the reason why MRNAs were used instead of VLPs in making the Pfizer BioNTech Covid-19 Vaccine. Caller wanted to know why Pfizer did not use VLPs and used MRNAs instead for the Pfizer BioNTech Covid-19 Vaccine and how many days are allowed to get the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine from the first dose. The outcome of the event was unknown.  Information about Lot/Batch number has been requested
After 5 days of administration of vaccine, patient noticed  bluish black bruise in his upper arm, arm was swollen and painful.
patient fainted after the vaccinations; cut her chin; This spontaneous report was received from a nurse via company representative and refers to a female patient of unknown age. No information regarding patient's pertinent medical history, drug reactions, allergies and concomitant medications.  On an unknown date, reported as recently, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strength, exact dose, dose #, route, anatomical location, lot # and expiration date was not provided). On the same day, she was also vaccinated with meningococcal vaccine a/c/y/w conj (dip tox)(MENACTRA), influenza vaccine and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (strengths, exact doses, dose #, routes, anatomical locations, lot # and expiration dates were not provided). The vaccines were given all together and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was administered at the very last. After the vaccinations, the patient fainted, fell off the table and cut her chin. She sought medical attention. She recovered from fainting while in the office. The patient had a follow up appointment to address the chin cut resulted form the fainting event. The outcome of the event of chin cut was reported as recovering.  The causality assessment was not provided.   Upon internal review, the event of syncope was determined to be medically significant.
This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site pain in a female subject of unspecified age who was vaccinated with FLUARIX Quadrivalent (GlaxoSmithKline). On 23 or 24 October 2013 the subject received unspecified dose of FLUARIX Quadrivalent (unknown). In October 2013, within days of vaccination with FLUARIX Quadrivalent, the subject experienced injection site pain, injection site redness and swelling injection site. The nurse reported that she has seen an increase of pain, redness and swelling at the injection site after FLUARIX Quadrivalent in five female subjects; no other details were provided. The vaccine was administered between 23 and 24 October 2013. At the time of the report no other information was provided. The outcome of the events were unspecified. For the other cases please see A1048964A, A1048966A-A1048968A.
This spontaneous report was received from a pharmacist (the patient's mother) via a company representative referring to a female patient of unknown age. Concurrent condition included postural orthostatic tachycardia syndrome (POTS). Information about the concomitant medication and drug reactions or allergies was unknown by the reporter. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (strength, dose route, lot # and expiration date were not reported) for prophylaxis. On the next day, the patient passed out. It was unknown if the treatment was given and if the lab diagnostics or studies were performed. The outcome of the event was reported as recovered. The causality assessment was not provided. Upon internal review, the event passing out was determined to be medically significant.
It was second dose. Hot red welt at injection area of about 4 inches. 4inches of a round shape. Painful and very itchy. I went to the Emergency Room on Friday, March 12, 2021 because the lymph node on the left side of my neck appeared swollen.
Patient came into the clinic for her required Menactra vaccine for school. After giving vaccines to her and her 3 siblings, patient started feeling lightheaded and dizzy. She was then offered juice, and patient started feeling better, not as lightheaded and dizzy but reported feeling hot. We asked if she had ate before this appointment and she reports that she did not. Patient then said she was okay to return to the lobby to wait the 15 minutes with her brothers, who received their covid vaccine. Patient vitals were checked in the lobby of the clinic when she started to look pale. Vitals with were low. More juice was given and patient started to feel better and regained color.
The patient sat in the privacy vaccination area in front of the pharmacy for over 15 minutes (9:30-9:50AM) following the administration of the vaccine.   She then walked to the front of the store pushing her buggy.  In the "check-out" line, the patient begin feeling  "dizzy".  A couple of customers helped her sit on the floor so she did not fall.  An associate immediately called for a code white and then helped patient to sit in chair.  The patient was observed and then offered a snack and/or water which she refused.  Her son was contacted so that he could take her home.  When son arrived, approximately 30 minutes later, the patient refused a wheelchair and walked out of the store.  He spoke with me and believed that the vaccine was not the cause of the "dizzy" spell and stated that she has those occasionally.   I recommended not to leave her alone for a few hours and make certain that she rested today.  I also advised patient son that someone needed to be with her so that she could be driven home after the 2nd dose in 28 days.
After having a fever of a 101 and I was extreme fatigue, and I also did have soreness in my arm I did have a steel birth on April 28, 2021, autopsy report is still pending.
Adverse Event This writer was informed of guest who received the Pfizer vaccine (Lot#ER8731) in her LD on 4/16/21 for her second dose. Guests first dose was Moderna vaccine (Lot#045A21A)  at the  Drive thru clinic on 3/18/21. Intervention\Treatment\Why it Happened Guest received the Pfizer vaccine for her second dose instead of the Moderna vaccine, which was administered as her first dose. Guest and her son were informed of this information while in the Post Vaccination Area. Guest denies any adverse side effects ?I am feeling fine. I would not know the difference - honey; I am 90-years-old.? Guest was provided 15 more minutes of observation time. Guest reports no adverse side effects and this writer informed her that I would call and check on her Saturday 4/17/2021. Guest provided this writer with her telephone for a follow-up call. Guest son asked if she should receive the second dose of Moderna because of this event. This writer informed both, that this situation is not ideal. We should have administered the same vaccine for first and second doses the CDC does consider patient to be fully vaccinated, no second dose of Moderna is required at this time.  Outcomes This writer conducted ?Just in Time Training? to the vaccinator and requested that the Point of Contact (POC?s) conduct this training with each vaccinator and Clinical Screeners. Guest with no adverse side effects noted or reported. Called patient today at 11:23 am. ?I am doing just fine and thank you for calling.? Requested that guest follow-up with her primary care provider if she experiences any adverse side effects. Provided guest with contact information if she had any questions. At this time 16:53 hours guest or her son has not called with any questions.
Rash started next day, was greater than 6 inches around injection site, progressed to most of upper arm.
Mom called on 04/26/04. States child's left arm swollen at shot site and was "red and hot". Put cool clothes on arm. On Sat 4/24/04. Then on Sunday 4/25/04 swelling with redness and heat went from shoulder down to elbow on left arm. Took child to ER, was given IV steroids, sent home with Rx for Keflex 250mg 42tsp QUID and Prednisone 15mg 1 1/2 tsp QD x 4 days. To begin today was told to get follow up appointment with Pediatrician. Hasn't gotten appt yet. Diagnosis was allergic drug reaction with cellulitis. Mom states child is much better today. Inst to continue meds as inst get follow up appt with MD. If not continuing to improve, refer to pediatrician or back to ER. Mom states understanding.
I was diagnosed with COVID-19 5/18/22. I started feeling bad. I tested negative the first time and then tested positive the second time. My throat bothered me the most. It felt like I had shards of glass in my throat. I also had chills, body aches, and coughing. It ended up turning into bronchitis. The worst of it is over with now. This has lasted about 10 days so far.
6-7days p/vax pt devel h/a, fever, few anterior cervical notes rt submandibular, pharyngeal hyperemia;Strongly suspect a viral illness, mom requests this from be sent;
1st dose 2years ago, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received over 2 years ago from the reporting date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: The patient had not receive second dose of Shingrix. The reporter did not have the date or lot number information of the first dose.  At the time of reporting, second dose had not been administered. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Back started itching, noticed red bumps all over back, sore throat tried oatmeal baths, Benadryl.
No adverse event; 113 Bivalent doses administered after the BUD to patients 12 and up; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 11-Oct-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (113 Bivalent doses administered after the BUD to patients 12 and up).    Concomitant medications were not reported.  It was reported that 51 doses from Lot AS7140C and 60 doses from Lot AS7148B were administered. No treatment information was provided.
Information had been received on 10-MAY-2017 from a lawyer regarding a case in litigation. It was alleged in litigation that a female patient (age unknown) was inoculated with ZOSTAVAX on or about 20-FEB-2015 at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (dosage and lot#/expiration not reported). The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. Three days after being inoculated, on or about 23-FEB-2015, patient was treated by physician for a rash that was diagnosed as severe shingles. Patient has been prescribed acetaminophen-codeine and valacyclovir to manage her painful symptoms. As a direct and proximate result of these malfunctions, patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages.  Additional information has been requested.
NONE - PT INADVERTENTLY RECEIVED 0.3 MLS UNDILUTED VACCINE
p/ vax pt hyporesponsive, febrile w/no known source, cyanosis, hypotonic episode
(L) arm with nickel size red indurations hot to touch at vaccine site. Give 1 tsp BENADRYL, apply ice & of becomes painful give MOTRIN, to be seen if increased swelling, redness or fever. No fever.
Headache, Myalgia, CoughWheeze, NauseaVomiting, Palpitations, Syncope, Arm pain, chills and overall weakness Narrative: Employee was unable to work second to symptoms, missing >1 days of work at time of this report.
cardiorespiratory sx devel 1 wk p/vax;extensive workup negative;saw an allergist as well; evidence has come to light that the vaccine actually caused these sx;
Almost immediately, pt c/o funny feeling going up her arm to her neck from the inject site then c/o numbness of jaw & tongue-VS stable; sx lasted x 1hr; To ER possible allergic reaction;
Patient with fever >102.0 less than 12 hrs after receiving immunization.  Patient resolved in 48 hrs without specific intervention.
Information has been received from a gynecologist concerning a female patient (age not reported) with lupus erythematosus who was vaccinated on an unknown date with the first dose of GARDASIL (lot #, route, and injection site not reported).  The outcome was not reported.  On an unknown date, the patient was vaccinated with the second dose of GARDASIL (lot #, route, and injection site not reported).  After vaccination, the patient's lupus erythematosus aggravated.  The outcome was not reported.  Upon internal review, the case was considered as medically significant.  Other business partner numbers include E2008-06022.  Additional information has been requested.
Swelling left eye upper lid; Swelling left eye upper lid; Hardness & redness at injection site; Hardness & redness at injection site; Hardness & redness at injection site; Dose received: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 18:30 (Lot number: FJ1611) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Sulfa allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dos: 2, Batch/Lot No: Ew0170, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 01May2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Batch/Lot No: Ew0151, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 08Apr2021, when the patient was 61 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 18:30, outcome "unknown", described as "Dose received: 3"; EYE SWELLING (non-serious), SWELLING OF EYELID (non-serious) all with onset 27Nov2021 09:00, outcome "not recovered" and all described as "Swelling left eye upper lid"; VACCINATION SITE DISCOMFORT (non-serious), VACCINATION SITE REACTION (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 27Nov2021 09:00, outcome "not recovered" and all described as "Hardness & redness at injection site". Therapeutic measures were not taken as a result of eye swelling, swelling of eyelid, vaccination site discomfort, vaccination site reaction, vaccination site erythema.  Additional Information:  Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No; List of any other medications the patient received within 2 weeks of vaccination: Various rx; Prior to vaccination, was the patient diagnosed with COVID-19?: No; Since the vaccination, has the patient been tested for COVID-19?: No.   Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.
Patient report that she started having chest pains that come and go back in August that lasted for awhile... then in Sept when she breathe she had horrible chest pain to where she had to taken to the hospital... she was told that she has Double pneumonia and was put on antibiotics.... 3-4 days late went to quick care because she wasnt feeling any better... she was told that it was fluid on lungs and one lung the doctors couldnt hear... 25oz of fluid was drained from one lung and 15 oz from the other lung all coming from the heart
Deep muscle and bone pain in extremity and back occurred in all extremities. Dr. felt the Td vaccine was the cause of the problem. Also c/o headache x 3 days. Now resolved as of 4/7/03 5pm.
postherpetic neuralgia; scleroderma; herpes zoster; Information has been received regarding a case in litigation from a lawyer and referred to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 30-MAR-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX), the patient suffered herpes zoster, postherpetic neuralgia, scleroderma and Raynaud's disease. As a result of these symptoms, the patient was seen and treated by her medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms had resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacturer, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events herpes zoster, postherpetic neuralgia and scleroderma was considered as not recovered. The causality assessment between the events herpes zoster, postherpetic neuralgia, scleroderma and zoster vaccine live (ZOSTAVAX) was considered as related by the lawyer.    The lawyer considered the events herpes zoster, postherpetic neuralgia and scleroderma to be disability. Upon internal review, scleroderma was determined to be medically significant.
His reaction he felt like he had pneumonia, legs and arms hurting, stomach hurts and fever.
Fussy, cranky several hours, post vax. Dad is ill with sore throat. Pt is eating well. No fever, vomiting or diarrhea. Seen back in office on 6/14/01, because crankiness persisted and increased. Admitted for septic work-up because baby was inconsolable. Septic work-up was negative. Treated 2 days with IV antibiotics then discharged.