chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report has been received from a Health Professional concerning a 55 year old, Male subject, who had been receiving FLUMIST, (intranasal). FLUMIST started on 16-Oct-2013. The reporter stated that the patient had received FLUMIST over age 49 which started on 16-Oct-2013. The outcome of the event of received FLUMIST over age 49 is unknown. The report was considered to be non-serious. Follow-up of insignificant information received by Astrazeneca/MedImmune 25-Oct-2013 from Health professional: reporters tab updated.
Patient presented to ER with Grand Mal seizure. Patient became apneic and was intubated. Pt was transferred to hospital ICU approx. 2:45 AM. Patient reported to have possible febrile reaction to routine vaccines. EEG was performed which was normal. Pt was extubated 3/29/18 10AM. Stable condition.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine administered 9 days after 1st punctured. No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up appended on 29-sep-2021 and contains non significant information
I have swollen lymph nodes as of noon yesterday. They are only along the left side of my body. The locations of the swollen lymph nodes are above my collar bone, arm pit, and groin.
I feel like I have the flu: achy muscles all over (even my lungs feel a bit cottony and heavy), very sore shoulder at injection site, very cold, tired.
While waiting the 15 required minutes after the shot was administered..I experianced a headache and left jaw discomfort. Minor arm pain the first day, I expected that. Did my regular errands and was fine, a little tired.  The next day, (Sunday)...I went to church, had a headache, arms aching like mad, arthritic symptoms , legs cramping, joint pain in elbows especially, were off the chain!  I returned home and took immediately to the couch, where I had a low grade fever and stayed all day. I had no appetite, no energy to get up except to go to the bathroom.
1/23/21 got the vaccine. Was fine till the evening. Started feeling the heart rate increasing. Soreness at the site. Fever was 103 that day. Next day 8am noticed hear rate was fast. Still felt hot. During the day heart rate kept increasing started getting sweats. Diff breathing, weakness, dizziness. Wanted to call EMT. But went to the ER on own. BP was high, HR /160.   Gave medication for the heart to slow down the rate. Was given Emtoprolol in the ER.  Was in the ER for several hours.
Rash on arm near injection site, about 3 inches in diameter, red and firm and slightly warm to touch, slight itch.
PATIENT REPORTS PAIN UPON NEEDLE ENTERING ARM AND THE VACCINE ACTUALLY ENTERING  HIS MUSCLE. OVER THE COURSE OF THE NEXT FEW MONTHS, HIS PAIN RANGED FROM 1-8 ON THE PAIN SCALE. THE PAIN WAS SOMETIMES ACCOMPANIED WITH LOSS OF FEELING, NUMBNESS, DOWN THE ARM AND OVER THE SHOULDER INTO THE BACK. SEVERAL TIMES HE  THOUGHT HE MIGHT HAVE BEEN HAVING A HEART ATTACK. RANGE OF MOTION WAS DECREASED AT TIMES BUT HAS NOW RETURNED TO SOMEWHAT NORMAL ALTHOUGH THE PAIN IS STILL PRESENT. PATIENT HAS USED SEVERAL OTC OPTIONS FOR PAIN, INCLUDING ACETAMINOPHEN, PAIN PATCHES, AND SUPPLEMENTAL CREAMS. THESE HAVE PROVIDE SOME BENEFIT BUT THE UNDERLYING PAIN, WHILE SOMEWHAT BETTER, REMAINS.
Information has been received from a pharmacist concerning a patient who was vaccinated with varicella virus vaccine live. The patient developed a fever on the same day of vaccination. Approximately 7 days later, the patient developed 1 raised lesion around the injection site that was peeling. Unspecified medical attention was sought. Additional information has been requested.
Information has been received from a consumer referring to her 28 year old non-pregnant daughter. The patient had no concomitant medication, pertinent medical history or drug allergies/reactions. On 12-APR-2016 the patient was vaccinated with a dose of unidentified Merck hpv vaccine (name, lot number, dose and route unspecified). The reporter initially reported an suspicious color of the GARDASIL or GARDASIL 9 that was administered. As a precaution a product quality complaint (PQC) was filed. A few hours later, on the same date, the patient started experiencing a sore throat; problem swallowing and muscular aches around her neck area. The patient did not seek for medical attention. No lab diagnostics study was performed. The reporter administered an unspecified dose of BENADRYL to her daughter and the symptoms subsided. The vaccine series was not discontinued. Additional information has been requested.
Patient presented to clinic for second dose of Pfizer Covid vaccination. Staff that pulled up dose forgot to add diluent prior to withdrawing dose, and patient received 6 doses. Error was recognized when the next patient presented to clinic. Error was immediately reported to medical director. Patient was called and reported no side effects. Patient was contacted 12 and 24 hours later and reported no side effects.
Developed stridor, cough with resp distress. Received epinephrine in ER, admitted overnight.  12/2/08 Reviewed hospital medical records of 11/21-11/22/2008. FINAL DX: croup Records reveal patient experienced sore throat, fever & barky cough x 1 day on the day he received the vaccination.  Symptoms worsened that evening to include stridor.  Tx w/nebs in ER w/o improvement & admitted for observation & management.   Tx w/steroids & d/c to home on continued steroids.
pulmonary inflammation; swelling of the lymph nodes in his arms; pulmonary distress; triggering an underlying condition of reactive airway disease; triggering an underlying condition of reactive airway disease; constant need to cough; felt like he had fluid on his lungs; swelling under the arms/swelling of the arms; body aches; Fever; The initial case was missing the following minimum criteria: adverse event. Upon receipt of follow-up information on 28Jan2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 56 year-old male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "reactive airway disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PNEUMONITIS (medically significant), outcome "unknown", described as "pulmonary inflammation"; PULMONARY OEDEMA (medically significant) with onset 30Dec2021, outcome "unknown", described as "felt like he had fluid on his lungs"; PERIPHERAL SWELLING (non-serious) with onset 29Dec2021, outcome "not recovered", described as "swelling under the arms/swelling of the arms"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swelling of the lymph nodes in his arms"; PAIN (non-serious) with onset 29Dec2021, outcome "unknown", described as "body aches"; PYREXIA (non-serious) with onset 29Dec2021, outcome "unknown", described as "Fever"; LUNG DISORDER (non-serious), outcome "unknown", described as "pulmonary distress"; BRONCHIAL HYPERREACTIVITY (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 30Dec2021, outcome "unknown" and all described as "triggering an underlying condition of reactive airway disease"; COUGH (non-serious) with onset 30Dec2021, outcome "unknown", described as "constant need to cough". Clinical course: The patient stated that he is reporting a negative experience with the Pfizer vaccine. He took the vaccine on 29Dec2021 and that night had a standard more intense reaction relative to what is possible like swelling of the arms, body aches and fever. The next day it attacked his lungs with the swelling and it felt like he had fluid on his lungs triggering an underlying condition of reactive airway disease and the constant need to cough. The patient reported that the shot he had triggered pulmonary distress and pulmonary inflammation. Later clarified that he had swelling under the arms and swelling of the lymph nodes in his arms.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Mild stroke; She got from the Vaccine booster shot; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  An adult female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Primary Immunization Series Complete; Unknown Manufacturer), for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Mild stroke; She got from the Vaccine booster shot".  Clinical course: Pfizer Sales Representative stated, "There was a lady she didn't want me to, I told I was going to report it. she didn't want me to use her name but she just told me that a friend's of her daughter has a mild stroke. She got from the Vaccine booster shot (Clarified as Pfizer COVID-19 Vaccine booster shot). I think that, I thought she said that girl was like 21 and 22 that was a late at girl but she didn't give me any information in terms of anything, it's just the booster and she was 21, 22. Her friend told her about it." When paraphrased the concern: Pfizer Sales Representative stated, "You didn't get me anything out, the age is just 21 or 22. Female." Other Medical History and Concomitant Medication: Pfizer Sales Representative stated, "No."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pfizer Comirnaty vial opened on Thursday 7/7/22 at 11:48am. Vaccine administered on Friday 7/8/22 at approx 3:15pm.
tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for COVID-19) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (tested positive for COVID-19). At the time of the report, COVID-19 (tested positive for COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
12:18pm: Client was complaining of hot face. Upon observation patients face was very red and a bit swollen. Clients temp was 97.1, BP 140/90. Asked client to pull down face mask, client was very red with darker red spots all over her cheeks. Client states she does have rosacea. Client also complains of throat tightness and tingling lips, dry throat. Face continues to stay red. .5ml of adrenalin given IM left thigh. 12:20 Client face looks slightly better but client still has tingling lips. 911 was called. Client able to have a conversation, no problems breathing. No worsening of symptoms of throat tightness or lips tingling. 12:28 BP 140/80, O2 sats 97 on room air, pulse 83. Client husband is at her side. Client states she is still doing ok, but this does feel like when she has had an allergic reaction before. Note per RN Ambulance arrived at approx. 12:23 pm - transported to Health facility, RN.
Information has been received from a registered nurse in an allergist's office and a physician concerning a 5 year old male with no known allergies or medical history who on 17-MAY-2006 was vaccinated SC in the deltoid with a second dose of MMR II (lot # 651110/1048R). Concomitant vaccination included a fifth dose of TRIPEDIA (lot # 017774CA) given IM in the deltoid. There was no illness at the time of vaccination. Approximately 15-20 minutes after vaccination the patient developed shortness of breath, hives, generalized pruritis and redness. The patient was also eating an orange lollipop (Dum-Dum) at the time. The patient presented to the ER and was treated with unspecified steroids and BENADRYL. ON an unspecified date the patient recovered. On 02-AUG-2006 the patient was seen by an allergist and was round to have a questionable reaction to the gelatin in the MMR II (lot # 651110/1048R) or to the lollipop. No further information was available. There was no product quality complaint involve.
Itchy arm the following morning around 6:30 am from the vaccine along with redness, swollen, hard lump.  Felt hot and sore
Symptoms started 5 months after vaccination, common diarrhea and frequent headache, joint pain and general tiredness. I went to the emergency because I thought I was going to die, I thought I had the Corona Virus and still till this date I have diarrhea, it's not every day but it is every other day or every other week, but I have noticed some changes in my body behaviors.
Patient came in for a flu shot on 10/3/17. On 10/5/17, he began to feel pain at the injection site. Patient came in today to state that pain has not gone away. Patient received FLUVIRIN PFS. I suggested that he see his physician as soon as possible.
After 6 hours felt fatigued took a nap for 1.5 hours and then after 10 hours started with crippling joint/body aches and chills that lasted for 3 hours and felt nauseous and could not calm my body down, drank water and took tylenol every 8 hours.  Felt better the next day but got tired around 3:00 p.m. Took another nap for 1.5 hours and then started with chills and body aches, continued with Tylenol regime and felt normal.  It is now day 3 and I feel okay.
Mom noticed (R) upper thigh swollen, red, hot to touch and painful to infant with touch on 8/20/10. No fever. She gave Ibuprofen po q 6 hrs PRN x 3 days & sx started resolving over 3 days & (R) thigh area better by 8/23/10.
On approximately 1/21/99, the pt experienced tenderness at the injection site, malaise, and joint pain.
Arthus and erythemas  - swelling extended to hand and fingers severe pain for 3 days. Today still has some pain today.
Patient was given the 2nd Pfizer vaccine 5 days before the recommended time between the 1st and 2nd dose. Patient has been informed of the vaccine administration error.
I have chronic muscular tension in my left shoulder that was feeling better until 2 days after I got my booster. There is a lot of inflammation down my left shoulder, a pinched nerve down my back, face tingling on the left side and tingling in my left hand. I have an appointment upcoming with a chiropractor. I have been using heat and having my sister help me who is a physical therapist. Nothing has provided prolonged relief.
Pt. was administered H1N1 flu vaccine. Intranasal instead of intramuscular. No symptoms noted as of 12/16/09. Thinking that this is protocol no MD order in place.
Patient representative said the patient had redness, itching and the injection site was raised and warm. Advised patient to call her doctor.
Pt recvd vax & 1wk p/vax exp impotence; event lasted 3 wks;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Pertinent medical history, drug allergies or reactions were not reported. On 15-SEP-2014, the patient was vaccinated with a dose of (Oka/Merck) PROQUAD lot # K008185, expiry date: 05-DEC-2015 (dose and route were not reported) that underwent temperature excursion. Concomitant medication was not reported. No adverse effect reported. This is one of several reports received from the same source. Additional information has been requested.
Patient's mom noticed once she left pharmacy, that the band aid was placed very low on patient's arm.  She is concerned that the injection site can cause injury to the patient and is wondering if the shot was effective.  Spoke to manufacture and was told there is no need to redose the patient.
No adverse event; 2 doses were given beyond the 30 day refrigeration date (BUD).; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses were given beyond the 30 day refrigeration date (BUD).) and NO ADVERSE EVENT (No adverse event) in a 44-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 074B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-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 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses were given beyond the 30 day refrigeration date (BUD).). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 doses were given beyond the 30 day refrigeration date (BUD).) 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 (2 doses were given beyond the 30 day refrigeration date (BUD).).    No concomitant medication was reported. No treatment medication was reported.
Tested positive for COVID 02Jul2022.; Tested positive for COVID 02Jul2022.; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 05Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 04Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 57 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "GERD" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Nexium, start date: 01Mar2018. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 02Jul2022, outcome "not recovered" and all described as "Tested positive for COVID 02Jul2022.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (02Jul2022) Positive; (10Jul2022) Negative; (15Jul2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical courses: Tested positive for COVID 02Jul22022. Began Paxlovid evening of 02Jul2022 and took last dose morning of 07Jul2022. On 10Jul2022 tested negative for COVID (the patient had gone due to blisters on tongue and white patches so they tested her again). On 14Jun2022 began having head and chest congestion, headache, body aches. 15Jul2022 symptoms of headache and body aches increased and began chest congestion, and head congestion, feeling fatigued. Took COVID test and tested positive.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the events and the use of suspect product BNT162B2 cannot be fully excluded.
approx 10 mins p/vax pt exp local reaction occured; nodule approx 2cm to palpation, erythema approx 6cm diameter; cold pack x 20 mins, DPH given; no systemic reaction; observed x 1 hr;
I had a manic episode after having the shot. I had manic symptoms like hyperactive, talkative, lots of hyperactivity. I could not sleep. I was escorted to the ER by the police and the ambulance. They admitted me to the psych unit and I was there for 3 weeks and was discharged. Once I got to the hospital I got the treatment I needed.
After 1st shot felt sick for a couple of days and feeling crummy; felt like flu; headache; body aches; tired; was miserable; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old female patient received BNT162b2 (BNT162B2), on 03Apr2021 at 13:45 as dose 1, single (Lot number: ER8735) at the age of 60 years, in left deltoid for covid-19 immunisation. The patient's relevant medical history included: "Fibromyalgia", start date: 2000 (unspecified if ongoing); "falls", start date: 2020 (unspecified if ongoing), notes: Two falls in 2020 and tore knee and tore muscles on upper right side.; "Anemia" (unspecified if ongoing); "Overweight" (unspecified if ongoing). The patient's family history included: "Pre-diabetic", start date: 2019 (unspecified if ongoing), notes: Mother's family has sugar diabetes. The patient's concomitant medications were not reported. Vaccination history included: Flu shot (AE(s) prior vaccinations: Soreness in arm with flu shots. No lot or expiration for flu shot.), for Immunization, reaction(s): "Soreness in arm". The following information was reported: MALAISE (non-serious) with onset 03Apr2021, outcome "recovered" (Apr2021), described as "After 1st shot felt sick for a couple of days and feeling crummy"; PAIN (non-serious) with onset 03Apr2021, outcome "recovered" (Apr2021), described as "body aches"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Apr2021, outcome "recovered" (Apr2021), described as "felt like flu"; HEADACHE (non-serious) with onset 03Apr2021, outcome "recovered" (Apr2021); FATIGUE (non-serious) with onset 03Apr2021, outcome "recovered" (Apr2021), described as "tired"; FEELING ABNORMAL (non-serious) with onset 03Apr2021, outcome "recovered" (Apr2021), described as "was miserable". Therapeutic measures were not taken as a result of malaise, influenza like illness, headache, pain, fatigue, feeling abnormal.  Additional information: Patient was asking for herself because after the first shot, she felt sick a couple of days. She confirmed she had anemia and was overweight, prior to getting Pfizer COVID vaccines. Patient felt sick, started within an half hour, felt like flu, had headache, and it was just basically feeling crummy. No cough, diarrhea or throwing up. Just body aches and tired. Was miserable. Lasted 2-3 days and was fine. Getting sick after each dose occurred within 30 minutes of getting it. It was reported that, she had two falls in 2020 and tore knee and tore muscles on upper right side and messed up tendon on right wrist. Family Medical History Relevant to AE(s):Mother's family had sugar diabetes and she was 91 and did not have it. Just preventative so she does not get it. Dad died at 65 of heart attack. Mom had a rare lung disease, that she would not get because it is for skinny weight women and she would not be in that category. Relevant Tests: None.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201094976 same reporter/patient/product, different dose/AEs;US-PFIZER INC-202201094977 same reporter/patient/product, different dose/AEs;