chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The Area outside the 'injection site' 2 or 3 inches away from it is also sore; when I lay on it the first night I could feel the sting, now it's a tiny bit swollen the injection spot, feel the pain or slight swelling; when I lay on it the first night I could feel the sting, now it's a tiny bit swollen the injection spot, feel the pain or slight swelling; when I lay on it the first night I could feel the sting, now it's a tiny bit swollen the injection spot, feel the pain or slight swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The Area outside the 'injection site' 2 or 3 inches away from it is also sore"; PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "when I lay on it the first night I could feel the sting, now it's a tiny bit swollen the injection spot, feel the pain or slight swelling".  Additional Context: It was reported that three weeks ago patient  got  her first dose of Pfizer and it was very uneventful and everything was fine. she had a typical you know soreness at the vaccination site just for one night and everything was great. Today she  had her  second dose and as far as I know it went well, I feel okay but it's unusual it is different from the first time, so she  has a  little concern as  have pain in her arm, not only in the vaccination site but two or three inches away from it going towards the inside of my arm." "The pain was different this time. The vaccination site off course it is going to be soreness but the soreness is also in two or three inches away from the vaccination site going towards the inside of my arm.  .   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm Soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (headache) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Arm Soreness) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment product information was provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow-up information received on 26-May-2021 and updated event outcome
Fever started 10pm 10/20/2020. Had rapid onset of fever reaching 102 in AM per dad. Dad reports that child was in room temperature bath of water with dad present and seizure began. Dad pulled him out of the water, laid him on his right side at which time he started convulsing, foaming at the mouth and experiencing oral cyanosis lasting approximately 30 seconds. Dad stayed with patient for full length of seizure which was 3 minutes. He then called MD office at which time he was instructed to call 911 - at time of call, patient was lethargic. Patient could open eyes on command but no verbal response. Color had returned - no cyanosis at time of call and seemed to be breathing normally per parent. Patient was evaluated by paramedics and taken to Hospital for further evaluation. Patient was diagnosed with febrile seizure.
8/9/21 blurry vision, felt weak, 8/13/21 rash under arm pits, then hives and welts all spread to 98% all over body, welts and hives would disappear and reappear all over body.  8/15/21 woke up with face, eyes, hands and feet swollen went to emergency room, received a steroid shot, and benadryl.
diabetes; CTEPH; Bronchitis; blood clots in lungs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An 81-year-old male patient received BNT162b2 (BNT162B2), on 13Feb2021 as dose 2, single (Lot number: EL1283) intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HHT- Hereditary Hemorrhagic telangiectasia", start date: 1963 (ongoing), notes: Numerous electrocautery sometimes under sedatio most recent was 28Nov2022; "blocked arteries", start date: 2010 (unspecified if ongoing), notes: bannot take blood thinners due to HHT, Pertinent Details: Quad by pass 2010  for blocked arteries; "Cholesterol" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Heart" (unspecified if ongoing); "Nose" (unspecified if ongoing). Concomitant medication(s) included: SIMVASTATIN taken for blood cholesterol (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); BACTROBAN [MUPIROCIN] taken for nasal injury (ongoing); BETAPACE taken for cardiac disorder (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Time (24hr): 2-3 PM, Anatomical site of injection: upper left arm, Route of administration: Intramuscular , Batch/Lot number: EL1283), administration date: 22Jan2021, for COVID-19 immunization, reaction(s): "congested", "wheezing". The following information was reported: BRONCHITIS (disability, life threatening) with onset Feb2021, outcome "not recovered"; PULMONARY HYPERTENSION (disability, life threatening) with onset Feb2021, outcome "not recovered", described as "CTEPH"; DIABETES MELLITUS (disability, medically significant) with onset May2021, outcome "not recovered", described as "diabetes"; PULMONARY THROMBOSIS (disability, medically significant) with onset 2021, outcome "not recovered", described as "blood clots in lungs". The events "cteph" and "bronchitis" required physician office visit. Therapeutic measures were taken as a result of pulmonary hypertension, bronchitis and the patient received riociguat (ADEMPAS) 3x/day 2.5 mg. The patient had bronchitis in Feb2021. Treated numerous times with antibiotic in May2022 diagnosed with blood clots in lungs (which we were told actually slower up in Jul2021).The reporter and patient were not informed in 21Jul2022, they went to (withheld) in (withheld). New diagnosed with CTEPH (Chromic Thromboembolic Pulmonary Hypertension). The reporter and the patient received the first vaccine on 22Jan2021. The reporter had no problems whatsoever. The patient started wheezing and being congested, they did not suspect it could related to vaccine, they thought the patient had bronchitis and the Dr treated it as such, with antibiotics. He would get better and then it would start all over again. The reporter thought it was in May2021. The patient was diagnosed with diabetes. The breathing problems continued. The patient was put on riociguat and was at the full dose.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020963 same patient/product, different event and dose;
Broke out in my scalp and underneath my ring finger; Broke out in my scalp and underneath my ring finger; It was red; Itchy; it hurt; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (Broke out in my scalp and underneath my ring finger), FINGER DEFORMITY (Broke out in my scalp and underneath my ring finger), ERYTHEMA (It was red), PRURITUS (Itchy) and PAIN (it hurt) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cardiac disorder. Concomitant products included ALENDRONATE SODIUM (ALENDRONATE) for Osteoporosis, DULAGLUTIDE (TRULICITY), CLOPIDOGREL BISULFATE (PLAVIX), DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), PANTOPRAZOLE, GABAPENTIN and PRAVASTATIN for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (Broke out in my scalp and underneath my ring finger), FINGER DEFORMITY (Broke out in my scalp and underneath my ring finger), ERYTHEMA (It was red), PRURITUS (Itchy) and PAIN (it hurt). The patient was treated with BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE (NEOSPORIN TOPICAL) for Skin discolouration, at an unspecified dose and frequency. At the time of the report, SKIN DISORDER (Broke out in my scalp and underneath my ring finger), FINGER DEFORMITY (Broke out in my scalp and underneath my ring finger), ERYTHEMA (It was red), PRURITUS (Itchy) and PAIN (it hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       She wanted to know if there was sulfa in it Regular med: Four medications where not clear to agent. Consent given   This case was linked to MOD21-043773, MOD21-043774, MOD21-043775, MOD21-043777, MOD21-043827 (E2B Linked Report).; Sender's Comments:  MOD21-043773:Crosslink Guillory, Jacqueline MOD21-043774:Crosslink Guillory, Jacqueline MOD21-043775:Crosslink Guillory, Jacqueline MOD21-043777:Crosslink Guillory, Jacqueline MOD21-043827:Crosslink Guillory, Jacqueline
tested positive for covid on binax rapid antigen test 9/23/21- sx cough, congestion
Left deltoid redness and swelling noted with bruising which started in PM after injections. Referred to MD for evaluation.
I was told to email you to report an adverse event that happened to our patient .  Event happened 9/28/21.  Pt came in to get her Pfizer booster shot during her visit. One MA reconstituted the vaccine and another administered it. The next day when another booster was to be given to a different pt, the MA who reconstituted the vaccine the day prior was watching another MA doing it and realized that she had done it wrong on the previous day.   The MA thought that the Pfizer Covid 1- vial was a single dose vial so she took the 1.8ml of of the diluent and divided it amongst the 6 vaccine vials thinking they were single dose. The MA drew up the vial and administered the entire content to the patient for a total of 6 doses and .3ml of diluent.   The provider was made aware and he called the patient to inform her of the incident and to ensure there were no adverse reactions that the patient would need to come in for. Pt stated that she was just having localized soreness around the vaccine site. the provider advised patient to call our office if any symptoms become severe.   Discussion with the team included what had happened as well as what we can do to prevent the issue from happening in the future. We agreed that whenever possible we will have the clinic RN reconstitute and draw up the vaccines and if not available we will have 2 MA present during the reconstitution and drawing up of the vaccines as a double check. RN will check off all MAs from start to finish on reconstitution process. This was also reported to VAERS and the state.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown gender and age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 26-SEP-2012, the patient was inoculated with ZOSTAVAX by a healthcare provider as recommended for permanent prevention and protection against shingles and zoster-related conditions (dose, route, and lot # not provided). On an unknown date, the patient was diagnosed with shingles and/or zoster related injuries after and despite being inoculated with ZOSTAVAX vaccine and suffered serious mental and physical pain and suffering and required extensive medical care and treatment. On or about an unknown date in October 2012, the patient was treated by a healthcare provider for shingles. As a further proximate result, the patient had suffered and would continue to suffer significant medical expenses, and pain and suffering, and other medical related expenses which includes but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. Causality assessment was related.
At approximately 3:11 PM on 11/20/2021, male child arrives to vaccine site with his father. Child's father requests initial pediatric Pfizer dose to be administered to child.  Nurse attempted to begin administering dose and poked with needle in left upper arm. Needle was inserted approximately 3 cm, then child withdrew arm and moved away from nurse. Child was difficult to console, and none of vaccine dose was administered to the child. Pfizer pediatric dose was not given to child for safety reasons. This dose and syringe was wasted, per COSD Policy guidelines.
Patient complained of pain in left arm, states arm left "light" and like there was no blood flow. Initially he could not lift his arm.  He could not feel arm or make fist. Patient confirmed his arm felt numb when I asked. After about 10 minutes he stated it was better but still couldn't lift his arm and it still didn't feel like there was blood flow per the patient. After about 10 more minutes and some water the pt had full use of his arm and hand and only stated soreness at the injection site. I called patient around 5:00 PM and he stated that there was only some soreness but he was using his hand and arm like normal at that time.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 53-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 53 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with treatment start date was 09Nov2022 and stop date was 14Nov2022.  Clinical course: The patient did not receive other medications within 2 weeks. Vaccine lot unknown reason was not available/provided to reporter at the time of report completion,   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, the causal association between the events 'drug ineffective', 'COVID-19' and the suspect drug BNT162B2 cannot be excluded.
SORE ARM, ACHENESS DOWN TO LEG, STILL PRESENT TODAY (4WEEKS ) LATER
PATIENT WAS FINE WHEN THEY LEFT THE PHARMACY. REPORTED GETTING BLISTERS/RASH AROUND THE FACE AND NOSE STARTING 2-3 DAYS AFTER VACCINATION. STATED THAT THE BLISTERING/RASH DID NOT HURT, BUT THAT WHEN HE MOVED HIS MOUTH IT FELT DRY SO HE USED AN "ANTIBIOTIC CREAM" ON THE DRY AREAS. HE WASN'T SURE IF IT WAS A PRESCRIPTION OR NOT AND COULD NOT RECALL THE NAME OF IT. HE CAME IN TODAY (7 DAYS AFTER VACCINATION) AND HIS FACE SEEMED TO BE CLEARING UP. I SAW REDNESS/SLIGHT BLISTERING AROUND THE CORNERS OF THE MOUTH IN PARTICULAR AND REDNESS ON THE TIP OF THE NOSE.
Sore on the injection site for a few days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient just got his/her shingles shot two weeks ago.  Then he/she would go back in June for the 2nd one.  The shot was not bad, it just was sore on the injection site for a few days and not bad reactions to the vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Patient reports fever body aches, chills and uncontrolled shaking that kept pt awake pt states just now feeling better only took TYLENOL for symptoms. Pt said felt worse than normal side effects from a flu shot. Reported no swelling or redness at injection site just mild tenderness like last years shot.
No adverse event occured.  The patient was below the age at the time of the injection.  The provider followed up with the patient following the vaccine and the patient had no reaction of note.
A nurse reported the occurrence of an injection site reaction in a 6-month-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxia. The vaccine provider submitted a report directly to VAERS. The pt had no medical history, concurrent conditions or concurent medications. The pt experienced no adverse events following previous immunizations. On 02/11/2003 the pt received his 3rd injection of Infanrix (lot DTPA586A9). On the same date, he received injectinos of 7-valent pneumoccal conjugate vaccine (Prevnar, Lederle Labs). These vaccines were not injected into the same leg as Infanrix. On 02/12/2003 the pt developed an injection site reaction characterized by a "big red raised area, hot to touch". The pt was seen by the physician. The reporting nurse considered the injection site reaction to be related to Infanrix administration. The most recent information was received on 04/01/2003. As of 03/28/2003, the outcome of the injection site reaction was unknown. Comment: This is one of 4 subjects from this facility, out of more than 30 children immunized, who experienced adverse events following receipt of two lots of Infanrix. Please see reports A0397368A, A0399834A and A0399837A.
Information has been received from a medical assistant concerning a 12 month old male with asthma and no illness at the time of vaccination, who on 04-APR-2008 was vaccinated with a first dose of VARIVAX (Oka/Merck) (lot # 659726/1772U) IM into the left deltoid.  The baby was not crying at the time of vaccination.  Post vaccination, the baby became cyanotic and stopped breathing for approximately 10 seconds.  With stimulation, the baby began crying and breathing again.  No resuscitation was necessary.  Vital signs were normal.  Subsequently, the baby was fine.  Upon internal review, the patient's apnea was considered to be an other important medical event.  Additional information is not expected.
Fever of 101 - 102 that lasted for 48 hours.  I had no other symptoms and took only Advil for treatment.
On the 6th day after the first vaccine my auto immune issues flared up. I have not flared up for three years. I had extreme inflammation and pain in my wrists, fingers, right knee, back and sides, and left injection shoulder. I also had swelling in the lymph nodes in my gums and throat. This lasted a week and I called in sick and could not do my day to day things. I did not seek hospital help.  I am still not 100% but am feeling better. The reason for putting this in is because I want it documented and our vaccine injury site states you can only file a injury if it happens within 3 days of vaccine.
arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm sore). At the time of the report, PAIN IN EXTREMITY (arm sore) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information provided.
Approx 20 minutes after vaccination, pt's jaws felt numb, arms became tingly & throat began to feel swollen. Per protocol, gave 1 EPIPEN injection in thigh, paramedics came, pt felt better after EPIPEN but symptoms returned soon after. Pt given another EPIPEN and transported via paramedics to hospital.
herpes outbreaks (Jan and Feb) on my lips/herpes simplex on lips; tiny single blister; This case was reported by a consumer and described the occurrence of herpes on lip in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes simplex labialis (outbreaks of herpes simplex several times per year on lips at 6 years of age) and pain.   In December 2019, the patient received the 1st dose of Shingrix. In January 2020, less than 2 months after receiving Shingrix, the patient experienced herpes on lip and lip blister. On an unknown date, the outcome of the herpes on lip and lip blister were recovered/resolved.   It was unknown if the reporter considered the herpes on lip and lip blister to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and had two herpes outbreaks in January and February on lips and both were a tiny single blister that lasted less than a week. For tolerances of 2nd dose, refer case US2020AMR070650, reported by same reporter for the same patient.
pain on shoulder, radiating to neck, arm soreness, couldn't move arm, dizziness. symptoms x 3 days now
Mainly, I have had a runny nose that went into my chest that has made me cough a lot. I called in to virtual doctor and she issued me prednisone and cough pearls since it sounded dry at the time. It kept getting worse and 4 days later I did another virtual visit with my doctor who said it sounded like I had a viral bronchitis. My COVID-19 test finally came back positive. I received an Albuterol inhaler with cough syrup as well as Doxycycline.
Fever - began about 1:00 pm on day following my injection.  Temperature of 101.7 at 1:00 pm - declined to 100.8 by 4:40 pm - declined to 97.8 by 7:00 pm.  My temperature was 96 at 8:00 am this morning.