chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Recurring hives on torso and limbs since 3 days after 3rd shot; Hives appear every day in different places,are sometimes itchy, and then recede; Dose number 3; This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.  A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 07Dec2021 at 12:00 (Lot number: unknown)at the age of 31 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Eczema" (unspecified if ongoing). Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), administration date: 15Apr2021, when the patient was 30 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN, Route of administration: Unspecified), administration date: 15May2021, when the patient was 30 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 at 12:00, outcome "unknown", described as "Dose number 3"; URTICARIA (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Recurring hives on torso and limbs since 3 days after 3rd shot"; PRURITUS (non-serious) with onset 10Dec2021, outcome "not recovered", described as "Hives appear every day in different places, are sometimes itchy, and then recede". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of urticaria and pruritus.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Initial unsolicited report received from a consumer on 5 October 2015. This case linked to 2015SA154146, 2015SA154153 and 2015SA154190 (same reporter). This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA QUADRIVAL A-B VACCINE (batch number, dose, route and site of administration was not reported) on an unspecified date (over the week end). It was reported that the patient received the vaccine from the clinic for the last couple years and did not experience any illness. The patient's medical history and concomitant medications were not reported. On an unspecified date, following the vaccination, the patient developed little soreness (that usually comes from getting a shot). Lab data and corrective treatments were not reported. The outcome of event was unknown. List of documents held by sender: none.
vaccine administered at mass vaccination clinic on 3/10/21 by EMT. client reports two days later severe headaches started that progressed to facial drooping, face and neck swelling, tongue and nose numbness all on left side, and dry mouth on the 6th day 3/17/21. she was admitted for observation to HCP on 3/18/21 and was told by a neurologist that her diagnosis was Bell's Palsy and that she should not receive a 2nd dose of covid vaccine.  she reports that swelling and facial drooping have improved some but are still present today 4/6/21.
Petechiae under breasts; Rash; Fatigue; 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: EP7533) via an unspecified route of administration in the left arm on 05Apr2021 at 20:15(at the age of 52-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, asthma, fibromyalgia, obesity and had allergy to sulfa antibiotics. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN) , fluticasone propionate, salmeterol xinafoate (ADVAIR)  and azelastine (MANUFACTURER UNKNOWN), multivitamin (MANUFACTURER UNKNOWN) and D3 (MANUFACTURER UNKNOWN) for an unknown indication from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since, vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Apr2021 at 07:30 the patient experienced rash - petechiae under breasts within 12 hours of injection, improved rapidly and gone by 4th day after injection, fatigue - lasted 4 days. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of adverse events. The clinical outcome of the events petechiae under breasts, rash and fatigue was recovered on 10Apr2021.   No follow-up attempts are needed. No further information is expected.
pt recv vax 16APR97 & 17APR97 pt exp flu-like sx which included nausea & vomiting;by 18APR97 pt recovered;
Sore arm starting late night 4/2.  Starting around 9 am 4/3, severe body aches (legs, neck, arm), clammy feeling, chills starting  around noon, slightly nauseous, fever reached  100.9
Information has been received from a registered nurse and refers to a multiple unspecified patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions or allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of GARDASIL 9 lot # M004116 with an expiration date: 12-OCT-2017 (dose and route of administration were not reported). Administered doses of the vaccine experienced temperature excursion of 53. 8 degrees Fahrenheit for 23 hours, on an unknown date. There was previous temperature excursion which took 12 hours and 30 minutes with the temperature of 54.6 degrees Fahrenheit. No adverse effects were reported. Data logger was involved. This is one of several reports received form the same reporter. Additional information has been requested.
Information has been received from a Register Nurse (R.N.) concerning a 49 year old female patient who on 22-SEP-2007 was vaccinated subcutaneous into the left arm with a dose of Pneumovax 23 Lot #657143/0380U. Concomitant therapy included DTaP (unspecified) and influenza virus vaccine (unspecified), both vaccines were given in the right deltoid, On 24-SEP-2007 the patient called stating she had a fever all weekend, was vomiting, and developed a hand sized redness which started at the injection site of left arm travelling downward. She mentioned that the injection site was hot to touch. She was taking (Advil) and (Tylenol). The nurse called the patient on Tuesday morning as a follow-up. Patient told the nurse she was feeling terrible, and it was recommended she go to the Community Medical clinic. Tuesday, 25-SEP-2007 she went to the clinic. Her temperature was down and her white blood count was within normal limits. No blood cultures drawn. Patient was treated with Intravenous (IV) antibiotics and then released. On Wednesday, 24-SEP-2007 patient went back to the clinic, complaining her stomach was hurting and feeling achy over her body. She was treated with IV antibiotics and 2 liters of IV fluids and then released. On Thursday, 27-SEP-2007 client went to clinic, treated with IV antibiotics and released. It was reported that she would get IV antibiotics treatment on 28-SEP-2007 at the clinic. Physician at the clinic diagnosed client with stph infection, but no blood cultures were drawn. Patient was also treated with oral antibiotics (the names of the therapy was unspecified). Patient told the nurse that she was off due to the symptoms. As of this reports day the client had not recovered. The reporter indicated that the patient's adverse events fever, stomach hurting, feeling terrible, feeling achy all over her body and vomiting and being diagnosed having saph infection were disabling. The reporter also felt that getting IV antibiotics, IV fluids was an intervention to prevent a serious criteria and it was reported as an other medical event. Additional information has been requested.
No additional adverse events reported; administration of expired GARDASIL 9; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concomitant medications, concurrent conditions, medical history and drug reactions/allergies were not reported.  On 10-JAN-2022, the patient was vaccinated with HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) 0.5 milliliter (route not reported, lot # R036913, expiration date: 23-SEP-2021) for prophylaxis (expired product administered). No additional adverse events were reported.
Vaccine side effects: 3 degrees fever, headache, malaise; treatment was Tylenol. Diagnosed with Covid on 9/12/2022.  Positive Covid test, 4 degrees fever, body muscle aches, exhaustion,  lack of appetite for 4 days.  Fatigue for another 4 days.  Treated with Paxlovid, Tylenol.
Severe Pain in back of left knee radiating to front. Worse at night when trying to sleep or when transitioning position.  Eased with walking.
No adverse event; Patient received Moderna Covid-19 vaccine after the 30 day past use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the 30 day past use by date) and NO ADVERSE EVENT (No adverse event) in a 93-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (First booster dose Lot number 029H21B ) on 08-Dec-2021 and Moderna COVID-19 Vaccine (Second booster dose Lot number 059M21 A) on 19-May-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 15-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the 30 day past use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the 30 day past use by date) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received Moderna Covid-19 vaccine after the 30 day past use by date).    No concomitant medication was provided by the reporter.  Patient received Moderna Covid-19 vaccine after the 30 day past use by date no information was available on the patients primary Moderna Covid-19 vaccines. No other adverse reactions reported.  No treatment medication was provided by the reporter.
COVID Second dose.  Debilitating fatigue, body aches, joint pain, severe headache  beginning 5 hours after injection and lasting for 48 hours.  Milder symptoms of fatigue and injection site pain for an additional 72 hours.
Red urine; Feeling sick; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHROMATURIA (Red urine), MALAISE (Feeling sick) and FATIGUE (Fatigue) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On 18-Apr-2021, the patient experienced CHROMATURIA (Red urine), MALAISE (Feeling sick) and FATIGUE (Fatigue). At the time of the report, CHROMATURIA (Red urine), MALAISE (Feeling sick) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that the patients urine was red, she was feeling sick and tired from the vaccine.  No concomitant medications were reported.  No treatment information was provided.
Arm is still tender; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. In October 2020, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The patient received the dose of Shingrix and experienced arm tender which did not resolved till the time of reporting. The reporter did not consented to follow up. No further information was available.
This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes Zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix (received 1st dose 2 years ago from reporting). On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination and the reporter asked information for such situation. The reporter did not have patient information and stated that this was asked by a physician in their hospital. The reporter consented to follow up via email.
Information has been received from a LPN concerning an adult female with no known chronic medical conditions who on 21-NOV-2005 was vaccinated with Pneumovax 23 (lot #651330/1048P), 0.5 mL IM injection. On 22-NOV-2005, the pt called to complain that she could not raise her arm and she had redness and swelling at the site of the injection. Tylenol and ice to the are was ordered. Her husband called the physician on 23-NOV-2005 and stated the wife had elbow pain, redness, and swelling. The events were reported as not recovered. Follow-up information from the nurse on 28-NOV-2005 indicated that the pt had been instructed to call the physician's office if her symptoms worsened, As of 28-NOV-2005, the pt had not called the office back. The nurse considered the events could not raise her arm; redness and swelling at site of injection; and elbow pain, redness, and swelling to be other important medical events (OMIC). Additional information has been requested.
None but patient was given Menactra at age 10yrs 11mos. instead of Age 11 yrs. Menactra wasn't due until July 13, 2019.
He received his second dose of Covid 19 shot on day #19  before his 4-day grace period, the minimum interval for which vaccination can be considered valid.
Child left office and then was brought back with trouble breathing and itchiness over entire body.  Wheezing and urticaria were present.  Given nebulizer treatment and oxygen @2L/min.  Squad called and transported to Emergency Room
P-60 B/P-120/64  Patient slumped down while in sitting position and I laid her down on exam table.  Her eyes were closed and she began to tremor and all extremities became rigid.  This lasted about 5 seconds then she relaxed & opened her eyes and asked what happened.  She was confused she said & felt tired & not normal.
Dr took her  off work because of  swollen lymph nodes and neurological things.  Really sick all weekend long.  Swollen lymph nodes in clavicle  ,neck, cheek.  Dr. prescribed muscle relaxants
The vial was stored in the refrigerator beyond the expiration date, 03OCT2021; The patient received the expired vacine on 16Nov2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received the expired vacine on 16Nov2021) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator beyond the expiration date, 03OCT2021) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received the expired vacine on 16Nov2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the refrigerator beyond the expiration date, 03OCT2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received the expired vacine on 16Nov2021) and PRODUCT STORAGE ERROR (The vial was stored in the refrigerator beyond the expiration date, 03OCT2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Vials stored in the refrigerator on 04-Nov-2021. No temperature excursions and no adverse event were noted.  No treatment information was provided.
During the 15-minute observation period the patient became flushed and began complaining of a headache.  She then went unconscious and had tonic-like activity for approximately 2 minutes.  The patient subsequently stopped the seizure-like activity and woke up but was confused and was acting in a postictal fashion.  She was evaluated emergently upon arrival in the ED and noted to have an altered mental status.  Physician noted that this does not appear to be an allergic or anaphylactic reaction.  There was no evidence of rash and lung sounds were clear with no wheezing.  Subsequent CT showed a diffuse subarachnoid hemorrhage and patient was transferred to the Medical Center for further treatment.
On day 10, I woke up with a heated red patch 2 /38? x 2? that was not previously there.
Per provider onsite that documented progress note: 'Pt had feeling of heart racing at ~10min after booster dose. Pulse found to be 130, otherwise normal. Sensation of mild throat swelling; pt has eosinophilic esophagitis- thinks this may be related. No oral edema, sitting up, speaking in full sentences. Lungs clear. Heart rapid (100) but regular. Possible mild immediate allergic reaction vs anxiety. Medications give- Benadryl 25mg oral extended release. Follow up recommendation: follow for another 20 min , EMS if worsens. Pt has ride home.'
rash on his chest; metallic taste in mouth; light headness; shortness of breath; Initial information regarding an unsolicited valid non-serious case was received from a Consumer or non-health care professional (Patient) via Medical Information (Reference number- 00394250) on 15-Dec-2020.  This case involves a 67 years old male patient who experienced metallic taste in mouth (taste disorder), light headness (dizziness), shortness of breath (dyspnoea) and rash on his chest (rash), while he received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 24-Sep-2020, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number not and expiry date reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On 24-Sep-2020, the patient developed a non-serious metallic taste in mouth (taste disorder) 10 minutes following the administration of INFLUENZA VACCINE.  On 24-Sep-2020, the patient developed a non-serious light headness (dizziness) and shortness of breath (dyspnoea) several hours following the administration of INFLUENZA VACCINE.  It was reported that, patient went for a run later that evening and he felt better.  Before went to bed symptoms stopped.  On an unknown date, the patient developed a non-serious rash on his chest (rash) unknown latency following the administration of INFLUENZA VACCINE.  Patient was feeling fine. Rash lasted less than two days.  Details of laboratory data not reported.   It was not reported if the patient received any corrective treatment.  On an unknown date, the patient was recovered from events.  There will be no information available on the batch number for this case.
On 3/2 as I was driving I realized that the signs did not appear as clear as they did on the Day I received the vaccination.  I verified that my vision had changed by sitting in front of my computer and doing several normal tasks that I had done on 3/1 during my normal work day.  I all cases it was apparent that my  distant vision had substantially changed. It was true for both eyes. I saw an ophthalmologist who said their was no organic  problems but suggested cataracts. I asked if cataract s could change so dramatically and also asked how my cataracts compared to the last visit. Basically nada.  Since I work on the computer every day  as a CPA
Patient reported feeling feverish and reported passing out in the evening after receiving the 2nd dose of vaccine in the morning. He cut his face when he passed out and went to hospital for treatment.
Swelling and tenderness under right armpit the morning after the administration of the vaccination.  Swelling is slightly larger than a golf-ball.
suspected vaccination failure; had them a lot; vacinnation every year; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the vaccination failure, shingles and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The patient received Shingles vaccine every year which led to inappropriate schedule of vaccine administered. After receiving Shingles vaccine, the patient got shingles a lot. The patient suggested to get the Shingles shot before your first outbreak. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation of shingles were not provided.
Within 24 H of inj sudden onset of flu like sx & dizziness. Could not go to work. Typical arm discomfort present. Feeling better over next 24 H.
Headache, Myalgia, Arthralgia, Fever, Weakness, fatigue
Approx. 4 days following the 2nd dose of the vaccine I noted significant nose bleeds.  12 days following injection I had intense chest pain and went to the ED.  EKG, blood work, and chest x-rays were taken.  All came back clear.  Blood pressure was 162/96.  Chest pain was deemed to be musculoskelatal.  Took blood pressure readings 2 days later and it was 155/90.  Took regular readings over the following 3 days and it averaged 150/85.  Blood pressure remains high and general practitioner will try low dose blood pressure medications.
simple febrile sz 10 days p/vax;+ family history of febrile seizures;prognosis excellent;