chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event occurred immediately following vaccination. The child experienced an approximately "1/4 inch raised red area at injection site for less than a day"   otherwise the parent denied that the child had any adverse events after vaccination.  Patient was vaccinated on  the morning  of 12/30/2021 , by mid afternoon, parent reported the child with out adverse events. By 1/4/2022 parent reported the raised red area mentioned above but nothing further. Reported, "honestly she is fine"
Unconsolable crying x 2 hours occuring 4 hours after administration of Pediarix, Hib and PCV-7.  Over subsequent 4-5 days continued to be "much fussier than usual".
near syncope; shaking muscles in her arms and legs; numbness of extremities/ could not feel her legs or arms; tingling in her hands; weakness in arms and legs; muscle pain in legs; hands and feet pale; Patient was not acting right; Patient had to lie down for 30 mins as for she "was not feeling good"/patient did not know how she got to school's nurse; Initial and follow-up information has been received from the father concerning his 15 year old white daughter with acne, acne vulgaris, and a history of Renoe syndrome (shaking of her hands), and no drug allergies, who in August 2007, was vaccinated with a first dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) 0.5 ml. On 15-OCT-2007, the patient was vaccinated intramuscularly in the left arm with a second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) (Lot# 659435/1265U) 0.5 ml injection. There were no illnesses as the time of the vaccination. Concomitant therapy included doxycycline (ADOXA). The next day, on 16-OCT-2008 the patient experienced tingling in her hand, and muscle pain in her legs. the symptoms only lasted less then one day, but the following week she experienced weak legs and arms, and numbness and shaking muscles in her arms and legs. A possible diagnosis of Guillain-Barre syndrome was reported. The patient sought unspecified medical attention. No laboratory diagnostics  were performed. At the time of the report, the patient had no recovered. No product quality complaint was involved.   Follow-up information indicated that on 16-OCT-2007 the patient experienced faintness near syncope, diffuse numbness worsening at extremities, and pale hands and feet. An EKG was performed and was negative. A neurological examination was performed and was normal even with subjective symptoms. The patient's blood pressure was within normal limits. No fever was reported and there were no other findings. The patient recovered on approximately 27-NOV-2007 (previously reported as not recovered).   Follow-up was received from the physician's nurse via telephone who reported that other family members are his patients, but not this individual. The patient was not seen in the reporter's office and HPV vaccine was not given at their office.  Follow-up information has been received from a consumer concerning her daughter on 04-OCT-2021.  The consumer reported that on 15-OCT-2007 after her daughter received the second dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), she had to lie down for 30 minutes because she was not feeling well (malaise).  It was reported that the next day, on 16-OCT-2007,  the patient went to her school's nurse and mentioned to the nurse that "she did not know how she got there".  The reporter also mentioned that her daughter "was not acting right" (abnormal behavior) and that she could not feel her legs or arms (Hypoaesthesia). The outcome of not feeling well and was not acting right was not reported.  The causal relationship between the aforementioned events and of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) was not reported.
Information has been received from a nurse and the mother of a 37 month old male with a milk allergy that causes constipation and mild GERD and a history of upper respiratory infections for which he received levalbuterol hydrochloride (XOPENEX) aerosol treatments who on 02Feb04 was vaccinated IM in the right thigh with a dose of Hib conj vaccine. On 02Feb04 the pt was also vaccinated in the right thigh with a dose of poliovirus vaccine inactivated (unspecified) (Lot U0612), a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot A600A2) and a dose given SC of measles virus vaccine live  (Moraten) (+) mumps virus vaccine live (+) rubella virus vaccine live  (RA 27/3) (lot 644845/0138N). The pt's mother noted that one of the vaccines was given in his right thigh and one in his arm. The nurse reported that the sites of administration and manufacturers were not documented. Other concomitant medication included motelukast sodium. There was no illness at the time of vaccination. On 03Feb04 the pt's mother called the office with complaints of a reaction in the pt's leg. She noticed that he was twice as big as the other one, and it was red and hot to the touch. The doc suggested a multivitamin, and acetaminophen (Tylenol), diphenhadramine (Benadryl) and ibuprofen (Motrin) as needed. The mother reported that later that day the swelling had worsened, and he was unable to stand up. She brought him to the ER, and he was given cetirizine hydrochloride (Zyrtec), acetaminophen (Tylenol) and diphenhydramine (Benadryl) and prednisolone sodium phosphate (Orapred) 5mg (2 tsp). The ER diagnosis was an acute large local reaction of the right thigh. The pt was not admitted to the hospital. On 04Feb04 the mother reported that her son's leg was still swollen and hard, but the redness was gone and it was no longer hot to the touch. He was able to stand but he had difficulty walking. On 05Feb04 the pt was seen for follow up in the doctor's office, and according to the nurse, was considered recovered. The nurse believed this adverse event to be non serious. No product quality complaint was involved. Additional information has been requested.
numbing & tightness on the right side of jaw hinge area tiring from small events; numbing & tightness on the right side of jaw hinge area tiring from small events; numbing & tightness on the right side of jaw hinge area tiring from small events; This is a spontaneous report from a contactable consumer reported for herself. A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number: EWO186; Expiration date was not reported), via an unspecified route of administration, administered in Arm Right on 20May2021 (at the age of 49-years-old) as DOSE 1, SINGLE for covid-19 immunisation at hospital. Medical history included trigeminal neuralgia, rubber sensitivity and hypersensitivity (known allergies: cillians, latax powder) from an unknown date and unknown if ongoing. Concomitant or other medications within 2 weeks of vaccination included baclofen (BACLOFEN); misoprostol (MISOPROSTOL) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced numbing & tightness on the right side of jaw hinge area tiring from small events on 21May2021 07:00 hr. No treatment was received for the events. Clinical outcome of the events was not recovered.  Follow-up attempts have been completed and no further information is expected.
Soreness in arm administered; Soreness in neck; Soreness in back shoulder blade; Underarm lymph was swollen and hurting; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: en6204), via an unspecified route of administration in the left arm on 08Mar2021 at 13:30 (at the age of 52-years-old) as a single dose for Covid-19 immunisation. Relevant medical history included allergies to foods (unspecified) and medications (unspecified). Patient did not receive any other medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Mar2021, the patient experienced soreness in arm administered from neck to back shoulder blade. The patient reported that this soreness lasted for two days. On an unknown date in Mar2021, a week after, the patient experienced swollen and hurting underarm lymph. Therapeutic measures were taken as a result of swollen and hurting underarm lymph which included treatment with Tylenol. The patient reported that the pain had started to lessen but was still present. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. The clinical outcome of the event soreness in arm administered from neck to back shoulder blade was resolved on 18Mar2021. The clinical outcome of the events swollen and hurting underarm lymph was resolving at the time of report.   No follow-up attempts are needed. No further information is expected.
Patient received PREVNAR 13 and ZOSTAVAX on 7/13/2017. Patient reports that he experienced pain and numbness in arm on following day. Pain and numbness continues on 8/4/17, which is date patient reports adverse event to myself.
Date of expiry 01APR2022, Store in refrigeration on 4APR2022, Date of administration 12Apr2022; Expired vaccine administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) and PRODUCT STORAGE ERROR (Date of expiry 01APR2022, Store in refrigeration on 4APR2022, Date of administration 12Apr2022) in a 63-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 12-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date of expiry 01APR2022, Store in refrigeration on 4APR2022, Date of administration 12Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to patients) and PRODUCT STORAGE ERROR (Date of expiry 01APR2022, Store in refrigeration on 4APR2022, Date of administration 12Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The Pharmacist was calling to verify an expiration date for lot number 026L21 B. The pharmacist said that when his Pharmacy received this vaccine on 23FEB2022 that a Pharmacy staff member looked up the expiration date and came up with an expiration date of June 2022. However another Pharmacy Staff member looked up the expiration date of the Moderna Covid-19 vaccine in question and the expiration date is 01APR2022.Number of doses/vials: 80 doses administered. The vial did not undergo any temperature excursions. Caller mentioned 155 patients where vaccinated with expired doses from 2Apr2022 to 19Apr2022. The Pharmacist did not have any other information on the patients at this time.  Treatment medications were not reported.
patient received COVID vaccine on 1/11/2021 and passed away on 1/25/2021
Injection given in Left Deltoid. No complaints at this time of injection.  Arrived in waiting area at 0725.  At 0750 C/o feeling warm, skin clammy, alert and oriented x 3.  Felt like a hot flash. BP 141/75, P=74.     At 0754A states feeling much better, skin warm, dry.  BP 139/69, P=67  At 0757 Patient chatting, alert and oriented x 3, skin warm, dry BP 169/93, P = 76. patient left observation room with husband who drove her home
Administration of SHINGRIX vaccine led to substantial bruising and soreness at injection site. Within 12 hours, significant flu-like symptoms, including severe body aches, headache, convulsion-like chills, and gastrointestinal upset. Occurred with both initial dose and follow-up dose. Reporter is 50-year old male, good health. Symptoms prevented normal activities and were significant.
This spontaneous report as received from a pharmacist, who was also the mother of the patient, refers to a female patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On unknown dates, the patient was vaccinated with GARDASIL 9 (route and site of administration, lot # and expiry date were not reported) for prophylaxis and received all 3 doses in total. All of the doses were not agitated in the vial prior to administration and were all clear in appearance (the prescribing information states that the product should be a white cloudy color after agitation). No adverse effects were reported. This is one of two cases received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008739.
The patient came into the pharmacy today and showed me her arm. It had a round, raised, red area around the injection site (about 3 inches in diameter). I felt it and it was very warm. She said that did not happen after the first dose of Shingrix. She did mention she had allergy shots for 4.5 years and had a similar reaction to those. I advised her to watch it and report if it gets worse. Told her she could take benadryl, also told her she could take tylenol/mortin for the pain. She said she would come back if it got worse.
Patient received Kinrix and we did not realize it was only for ages 4-6 years old. Patient is 9 months old. No adverse events.
This spontaneous report was received through a company representative from a physician who saw a media report on a TV channel about a month ago, referring to a female patient of unknown age. Concurrent conditions or pertinent medical history were not reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot#, anatomical location, dose and frequency were unspecified). Concomitant medications were not reported. On an unknown date, the patient experienced general malaise, dizziness and tiredness after receiving GARDASIL. No product quality complaint was involved. At the time of the report, the outcome of malaise, dizziness and fatigue was unknown. The relatedness of GARDASIL with the adverse events was not reported. Additional information has been requested.
Moderna COVID-19 Vaccine   Fever, body aches, weakness, headache.  Headache started 12/29 all others started the morning of 12/30.
14 days status post vaccination, developed non-erythematous polyarthritis of wrists, hands, fingers, knees, and ankles. Diagnosed as viral arthritis.
her arm hurts; This is a spontaneous report from a Pfizer-sponsored program regulatory authority SUPPORT from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated her arm hurt on an unspecified date with outcome of unknown. She was asking what she can do for the pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Beginning 3 hrs after the shot, and lasting 5 days, I was unable to raise my left arm due to pain in my shoulder. The first night?s pain was intense and I was unable to sleep in any position. The slightest movement of my arm seemed to cause pain in that shoulder. It is almost
Myalgia, Arthralgia, Fever, NauseaVomiting, STOMACH UPSET, SORE ARM Narrative:  Other Relevant History:
N17.9 - Acute kidney failure, unspecified R65.10 - Systemic inflammatory response syndrome (sirs) of non-infectious origin without acute organ dysfunction VOMITING PERIPHERAL EDEMA
Headache, running nose, coughing, sneezing, dizziness, weak, hard to breathe, etc. and lasted more than 4 days so far. Still suffering.
He is having pain in his back; Pain; This is a spontaneous report from a contactable consumer (patient parent). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number and Expiry date was not reported) as single for covid-19 immunization. The patient received paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. Reporter stated patient got the second shot on Saturday and he was having pain in his back. When asked for further probing, reporter stated, want to know what could be done with the pain that all need to know. Treatment received in regard to events was aspirin. The outcome of events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
fever; chills; received expired dose of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received expired dose of the vaccine), PYREXIA (fever) and CHILLS (chills) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Autoimmune disorder. Concomitant products included PARACETAMOL (TYLENOL [PARACETAMOL]) for an unknown indication.    On 20-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received expired dose of the vaccine). On 21-Oct-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received expired dose of the vaccine) had resolved. At the time of the report, PYREXIA (fever) and CHILLS (chills) outcome was unknown.            Lyrical  is also used as concomitant for unknown indication   He was on medications for autoimmune disorder Treatment information was unknown
+swelling in rt thigh w/warmth; tx-heat APAP & DPH;
Starting at one week post vaccine I developed an itchy, red rash on my left lateral breast. That went away in a week. Dermatitis under my breast. Went away in approximately a week. Oral outbreak of herpes virus on lips and inside mouth and on tongue. Approximately a week to two weeks later developed esophagitis. Seen by Provider on 9/10/21. Placed on Valtrex and Clotrimaze troche. No evidence of thrush but  my Dr felt he wanted to cover all possibilities. I?m to contact him 09/17/21 and report any improvement or if not improving. I will FU with ENT if needed
pt recv recv vax 9APR96 & w/i 1wk pt exp itching, red rash which migrated to neck & wrists;pt seen by MD who treated sx w/steroid inj;sx cont;
Nocturnal chest tightness, rapid thready pulse, high blood pressure, fatigue and weakness. Symptoms began about 1:30 AM often on until 4 AM. Following day experienced mild fever and flu like symptoms.
Misadministration of full dose of Moderna 3rd dose.  in line for registration she was signed in for full dose Moderna with a red tag on her card.  she was brought to my station  and when  I asked about allergies and why she required immunocompromised dose she stated that she has severe asthma.  When asked whether she was being treated with high dose prednisone she answered yes.  but later she stated that with the mask she misunderstood the question as  was she ever prescribed prednisone and she was not on it chronically.   she therefore qualified for the 1/2 dose instead of the 0.5cc dose . She was given explanation that she may have a sore arm but there will likely be no bad outcome from the higher dose administration .  She seemed calm and not overly stressed about the  misadministration
Right side of face and throat went numb, felt as if I could taste the vaccine as it was being administered; Tingling feeling in face; This non-serious case was reported by a consumer and described the occurrence of numbness facial in a 54-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9XL7N) for prophylaxis.   Previously administered products included Flu vaccine (received every year).   On 03-DEC-2022, the patient received Fluarix Quadrivalent 2022-2023 season (intramuscular) .5 ml. On 03-DEC-2022, less than a day after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced numbness facial (Verbatim: Right side of face and throat went numb, felt as if I could taste the vaccine as it was being administered) and tingling sensation (Verbatim: Tingling feeling in face). The outcome of the numbness facial and tingling sensation were resolved with sequelae.   It was unknown if the reporter considered the numbness facial and tingling sensation to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.     It was unknown if the company considered the numbness facial and tingling sensation to be related to Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device.   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: 10-OCT-2023 This report was submitted via the online direct entry reporting system.  The patient stated that reaction to this vaccine was almost immediate.  The administering physician took my vitals and entered reaction information into their computer system, but why this happened was never resolved.  The patient still had slight numbness or tingling feeling on lower right side of my face or lip.  The patient had received flu vaccines every year since 2006 and this reaction had never happened to her before until this past year after receiving flu vaccine. Right side of face and throat went numb, felt as if she could taste the vaccine as it was being administered. The symptoms were not treated. The reporter agreed to follow up with GlaxoSmithKline (GSK).
Pleva. Had a Biopsy and was told it's a result of the covid vaccine.