chrisvoncsefalvay/vaers-outcomes huggingface dataset:
all of his bones in his body was aching; stated that he could hardly move; his eyes were hurting like his pressure was up; muscle pain; stiffness of muscles; eyes are hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 72 year-old male patient received bnt162b2 (BNT162B2), administration date 03Mar2021 (Lot number: EN6205, Expiration Date: 30Jun2021) at the age of 72 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back issues", start date: 1985 (ongoing). The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "muscle pain"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Mar2021, outcome "unknown", described as "stiffness of muscles"; EYE PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "eyes are hurting"; BONE PAIN (non-serious) with onset 12Mar2021, outcome "not recovered", described as "all of his bones in his body was aching"; MOVEMENT DISORDER (non-serious) with onset 12Mar2021, outcome "not recovered", described as "stated that he could hardly move"; OCULAR DISCOMFORT (non-serious) with onset 12Mar2021, outcome "not recovered", described as "his eyes were hurting like his pressure was up". Therapeutic measures were taken as a result of eye pain, ocular discomfort.  Additional Information: It was reported that 10 days later, He experienced muscle pain, stiffness of muscles, eyes are hurting - He wants to know if these symptoms are normal. Treatment: Stated that he put a heating pad on and used eye drops.  No follow-up attempts are possible. No further information is expected.
Shot given on Wed. Friday AM became ill with body aches, severe H/A, neck pain, chest pain, back pain, decreased abdominal pain, increased cramping, leg weakness, dehydration. Pt is also pregnant.  1/6/2010 ED records for 12/25/2009, patient  17 weeks pregnant with c/o's SOB, myalgias, fever, nasal congestion, headaches , myalgias and adominal cramping. Tx: IVF, IV Zofran, albuterol tx, DC DX post vaccination syndrome
On 07/27/04, pt woke up in AM with swollen right eyelid and one large hive on site of Japanese Encephalitis injection. Stated she "felt funny" going to bed on 07/26. Pt had a history of allergic reactions and has taken Claritin-hives medication with effective results. She did not want to take Benadryl. Advised pt to take Claritin-hives medication and if symptoms worsen to contact MD or if any respiratory involvement to go to the ER ASAP.  Pt agreed sent pt fact sheet on Japanese Encephalitis vaccine. Per pt applied topical cortisone to site of injection to relieve itching.
I spoke with patient today. He states that he had YF vaccine on 9-28-17. On the evening of 10-03-17 while watching TV he felt very fatigued and went to bed early. He later woke up with shivers and feeling cold as if he had a fever. This was better in about 30 minutes and he took TYLENOL which is made him feel much better. He took off of work 10-04-17 due to malaise and still not feeling well. Today he is feeling much better but has intermittent aches and feeling warm on and off. I highly encouraged him to see his doctor. He stated that he did not feel bad enough to see a doctor. I again encouraged him to get checked out by his doctor.  He said that he would see if he could get in today since he is traveling soon. He was very thankful for the discussion and advice.
First day: Upper body soreness beyond vaccination site, headache, sleeplessness; Second day: Physical weakness,  unable to regulate body temp (couldn't get warm), sleeplessness (woke up drenched in sweat); Third day: daytime felt ok. Nighttime had 3 intense nightmares back to back, with some sleep in between. ( I rarely have nightmares)  Fourth day: Feeling better in general, but those nightmares scared the bejusus outta me.
Vaccine was expired on 09-Nov-2021 and was administered on 27-Dec-2021 past expiration, doses were stored in the freezer before administration.; doses administered past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 27-Dec-2021 past expiration, doses were stored in the freezer before administration.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses administered past expiration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 27-Dec-2021 past expiration, doses were stored in the freezer before administration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses administered past expiration) and PRODUCT STORAGE ERROR (Vaccine was expired on 09-Nov-2021 and was administered on 27-Dec-2021 past expiration, doses were stored in the freezer before administration.) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The doses were administered past expiration. It was reported that the doses were stored in the freezer before administration. The vaccine was expired on 09-Nov-2021.  No concomitant medication was provided.
Received an expired booster dose; This spontaneous case was reported by another health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A, 047A21A and 034B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose). On 10-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Received an expired booster dose) had resolved.    For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine was expired on 22 December 2021. The vial was initially stored in the refrigerator on 06 January 2022. The vial did not undergo any temperature excursions. No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2022-447243 (Patient Link).
Severely unwell; 101-degree temp; Headache; Fatigue; Nausea; Muscle aches; Dizziness; This is a spontaneous report from a contactable Other-HCP. This Other-HCP reported that a 38-year-old female second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL 8982), via intramuscular in left arm on 01Feb2021 17:00, as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EK 9231), via Intramuscular in left arm on Jan2021 at 16:00, as 1st dose, single dose for covid-19 immunisation. Known allergies reported for penicillin, vicodin, percocet. The patient did not receive any vaccines within four weeks prior to the vaccination. No other medications in two weeks. On 02Feb2021, 09:00 the patient experienced a general feeling of being severely unwell, 101-degree temp, headache, fatigue, nausea, muscle aches, dizziness. The patient did receive any treatment for the event was unknown. Adverse event resulted in emergency room/department or urgent care. The outcome for all events was recovering.   Follow-up attempts are completed. No further information is expected.
sore left arm shoulder deltoid muscle./sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle./sore left arm) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A, 040A21A and 011M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle./sore left arm). At the time of the report, VACCINATION SITE PAIN (sore left arm shoulder deltoid muscle./sore left arm) outcome was unknown.            No Concomitant product use was reported.  The patient received their Moderna Covid-19 booster dose on 28-Aug-2021 and complained of a sore left arm shoulder deltoid muscle.  No treatment information was provided.   This case was linked to MOD-2022-461876, MOD-2022-461858 (Patient Link).   Reporter did not allow further contact
Re-dosing of moderna vaccine; Expired Vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 037C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used). On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine used) and EXTRA DOSE ADMINISTERED (Re-dosing of moderna vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication as provided No treatment received ed by the patient
pt w/hx of sz disorder  in OCT/96 & NOV96;approx 24 p/vax NOV96 pt devel a fever ax temp 104-105 & sz;taken to ER in post-ictal state, given IV fluids;observed overnoc & sent home;devel fever & sz 3-4wk;
fatigued; This is a spontaneous report from a contactable consumer (Patient). An 87-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, batch/lot number not provided), via an unspecified route of administration on an unspecified date (at the age of 87-years-old) as dose number unknown, single for COVID-19 immunisation. No medical history and concomitant medications were reported. It was reported that on an unspecified date, the patient was fatigued. The patient was enrolled in the patient assistance program, the patient shared her experience with the COVID-19 vaccine that she receives, and she knows they have to report those. Patient stated that she was fatigued and all in all her vaccines were successful. Patient stated most people thought the side effects were less with the Pfizer shot. The outcome of the event was unknown.  No follow-up attempts are needed. No further information expected.
Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 70 years old patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot: UJ022AB; expiry date: 18-Apr-2019) via intramuscular route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no other vaccines administered. It was a case of actual medication error due to exposure via skin contact and vaccine underdose since the vaccine ran down the patient's arm and probably did not get much of the vaccine. The bulk leaked out while nurse pulled the needle from the patient's skin. It was reported that the leak was around hub where the needle was attached to syringe and from the patient's arm when it was pulled out. It was also a case of syringe issue. It was not reported whether the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Red circle around injection site-no treatment has been given as he shows no discomfort from it.
A non-serious spontaneous report of gave half the total dose of FLUMIST was received from a physician concerning a female child, subsequent to FLUMIST.  The patient received FLUMIST on 06-Nov-2008.  A physician from the Centers for Disease Control and Prevention reported that his office received a report of 31 children ranging in age from five to seven years of age who received half of the total dose of FLUMIST in one nostril.  The other half was discarded.  There was no adverse event associated with this medication error;  therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.  Additional information was received on 24-Nov-2008 that included the following:  demographic data, date of vaccination and confirmation that none of the children experienced adverse events.
Developed abdominal pain on 3/25/2021 and developed bilateral leg pain on 4/2/2021. Bloodwork and ultrasound of legs were normal. Advised to follow-up with PCP.
nausea; vomiting; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team. The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Cardiac Disorder" (unspecified if ongoing), notes: Caller stated she has APS and is a cardiac patient too; "APS" (unspecified if ongoing), notes: Caller stated she has APS and is a cardiac patient too. The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), outcome "unknown"; VOMITING (non-serious), outcome "unknown".  Additional information: Caller mentioned she had been taking Pfizer products from the very beginning. She mentioned she was vaccinated with the primary series and two boosters, all from Pfizer. She mentioned she got a reaction a couple of times, with nausea and vomiting all night, until 7:30 am. Last booster was in Jul. She mentioned she was concerned about getting the Omicron vaccine and that she was allergic to something vaccine. Caller asked if in stoppers or syringes may have latex. Caller also mentioned she just recently received a Flu shot and asked how long should she wait to get the new Omicron vaccine. Caller also mentioned there were new two variants that have come out. So that was totally absurd, because the virus was constantly mutating, and that people were still getting COVID and Omicron, so it does not prevent anything. Caller expressed her main concern was if she should talk it or not because she was afraid of getting the reaction and to be up all night. She also mentioned her doctors do not know how to treat or prevent the side effects from these vaccines. She asked if the Pfizer product get into the valves of the heart. Caller asked when can she receive the bivalent vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Seriousness criteria Other medically significant (OMIC). From initial information received on 4/4/2006 from a literature report entitled PET scan hypermetabolism induced by influenza vaccination in a patient with non Hodgkin lymphoma. It was reported, that a 10 year old boy developed an intense hypermetabolism area on positron emission tomography PET scan after receiving influenza virus vaccine. The boy, who was two years off therapy for non Hodgkins lymphoma, received an influenza virus vaccine (dosage not stated) in his left deltoid muscle and, nine days later, a routine PET scan showed an intense hypermetabolism area in his left axillary region and a smaller hypermetabolism area in his left supraclavicular area, a disease progression was suspected. The boy underwent excision on his lymph node (1.3 in greatest dimension), a reactive lymph node with evidence of follicular and interfollicular hyperplasia was found. Eight months after the initial PET scan, another hypermetabolic lymph node was found in his left axilla with about half of the metabolic intensity of his initial node. The node (2.5 cm in greatest dimension) was excised and was found to have florid hyperplasia with no lymphoma evidence. Author comment, the intense isolated hypermetabolism areas on two occasions, the pathological findings of reactive lymph nodes and the boys continued good health nine months after the initial PET scan, support the hypothesis that this hypermetabolism area (occurred as a result of local antigens processing and lymphocyte proliferation in response to the patients influenza vaccination). A search did not reveal any7 previous case reports of hypermetabolism associated with influenza virus vaccine.
Pt experienced nausea for 15 minutes after receiving vaccine with one episode of emesis. Pt reports nausea may be related to home medication which occasionally causes nausea for pt.
Information has been received from a physician concerning a patient who on 04-JUN-2006 was vaccinated with a dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine).  The physician reported that in 2006, the patient developed diarrhea.  Unspecified medical attention was sought.  Stool samples were obtained for testing (results not provided).  Three weeks after onset, the patient's diarrhea resolved.  Additional information has been requested.
Fever 102,  Body/joint pain,  elevated heat rate 120?s lasting about 14 hours    Alternated taking Tylenol and Advil
Tested positive for COVID on 10/29/21, received monoclonal antibody infusion; 11/1/21 c/o increasing SOB and chest discomfort; taken to ED where he was hypertensive; hypertension treated; COVID pneumonia and acute CHF exacerbation; placed on BiPAP; transferred to ICU; given Decadron and Remdesivir; Ejection Fraction 25-30%; DNR/DNI; pt was transferred to a Rehab center in stable condition on 11/6/21; pt then dc'd to home from rehab center where he passed away naturally with cause of death being COVID 19 pneumonia
Body aches, headache, chills, nausea, lethargy,  Low grade fever (100.2 oral)
Severe nausea, vomited x 1, pale, Vital signs 120/82 pulse-90 R-16, wet compress applied to forehead, given Sprite, and mint chewing gum. After 10 minutes patients normal color returned, reported only mild nausea, no vomiting. No SOB or edema noted throughout the entire GI episode. 1 hour later still with mild nausea only. Reported left work around 11:30 AM due to nausea. States vomited x 3 at home. Is back to work today 10-11-12 with no symptoms.
5 mins after the injections were given child was notice by medical assistant falling off table; eyes rolled; shaking; became incontinence of urine. Child transported to hospital by ambulance.
Woke up the week end of June 26th not able to close my jaw, thought it was TMJ, went to the dentist on June 28th.  On July 10 food was accumulating in my right jaw, I had to use my finger to remove it.  I started talking like I have been to the dentist with nonvaccine.   The whole right side of my face was dropping so I went to the emergency room thinking I was having a stoke.  They diagnosed it as Bell's Palsy.  To this day 8/18 my right side of my face has numbness.
Digestion issue: bloating, pain, discomfort, & loss of appetite. Similar to gall bladder issue before having it removed. Slight headache.
The ring went away and reappeared; Ring about 3 inches around injection site; A spontaneous report  was received from a healthcare professional concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events ring about 3 inches around injection site/ vaccination site reaction, the ring went away and reappeared/ symptom recurrence.  The patient's medical history was not provided. Concomitant medications reported were Multivitamin and Supplement.  On 22 Feb 2021, one day prior to the onset of the events the patient received their dose of mRNA-1273 (lot/batch: 042L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 23 Feb 2021, the patient experienced the event ring about 3 inches around injection site. On 3 mar 2021, the patient experienced the event the ring went away and reappeared  Treatment details included hydrocortisone cream to the skin to treat her symptom.  Action taken with mRNA-1273 in response to the events was not reported.   On an unknown date, the outcome of event, ring about 3 inches around injection site was resolved. The outcome of the event ring went away and reappeared was unknown.
This spontaneous report as received from a physician refers to an one year old male patient. None pertinent medical history and drug reactions or allergies were reported. On 28-NOV-2014, the patient was vaccinated subcutaneously with one dose of (Oka/Merck) VARIVAX, (frequency and anatomical location were not reported) (lot # was reported as K005426, expiration date: 15-APR-2016) as routine vaccination. Concomitant medication was not reported. On 05-DEC-2014 after receiving (Oka/Merck) VARIVAX, the patient experienced fever of 102 F, cough, and congestion. This was diagnosed as an unspecified ear infection. Patient also developed a "chickenpox-like" rash at the injection site, described as a lesion which "started off as a red disc for the first few days, then developed a white bump." Patient received cefdinir (dose and frequency were unspecified) for treatment. No laboratory test were performed. The patient sought medical attention (office visit) (exact date was not provided). No product quality complaint was reported. The outcome of unspecified ear infection and "chickenpox-like" rash at the injection site was reported as recovering at the time of the report. The relatedness between the events and (Oka/Merck) VARIVAX was not reported. Additional information has been requested.
Symptoms from October 2014 exacerbated. Loss of leg control in both legs;buckled at the knees, weakness. Additional symptoms manifested to include paresthesia, ataxia, weight loss, muscle pain, bone pain, in addition to exacerbated symptoms initially reported: headaches, joint pain, difficulty walking, back pain, chronic fatigue, pain, intermittent numbness in face and arms.