chrisvoncsefalvay/vaers-outcomes huggingface dataset:
has been really shaky; has a headache; hasn't felt good; when she went to sleep she woke up 2 hours later; couldn't move her arm; cold chills; she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure; she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure; sharp pain throughout her arm; This is a spontaneous report from a contactable consumer (patient). A 20-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 27May2021 (at the age of 20-years) as 1st dose, single dose in the left arm for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient side effects are that she has been really shaky, she has a headache, she hasn't felt good since yesterday, 27May2021, and she went to sleep yesterday, 27May2021, and woke up 2 hours later and couldn't move her arm at all and every time she did move it, it was shooting sharp pain throughout her arm, she has cold chills and she believes she was running a fever last night because she was burning up but she couldn't find a thermometer though so she is not sure. Clarified vaccine to the Pfizer COVID vaccine 1st dose. Reporter seriousness was Unspecified. She says they are all continuing to today except for she doesn't have the fever anymore and her arm is not shooting pain. But she does still have headache and cold chills every now and then and she's shaky. The outcome of the events Sleep disorder; Joint range of motion decreased; Fever; Burning sensation, Pain in arm was recovered in 2021. and rest of the events was not recovered.  Information on the lot/batch number has been requested
Tiredness; This case was reported by a nurse via sales rep and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional details were provided as follows: The patient was co-worker of reporter. The age at vaccination was not reported. The patient reported that after immunization they were tired for 1 to 2 days. This case has been linked with case US2019AMR097312, US2019AMR097048reported by the same reporter.
Arm pain; Initial information was received on 22-Sep-2021 regarding an unsolicited valid non-serious case from other health-care professional.  This case involves a 57-year-old female patient who had arm pain (pain in extremity) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  It was unknown if the patient had any medical history, concomitant disease or risk factor.  Medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 22-Sep-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (batch number and expiry not reported) via unknown route in unknown administration site for prophylactic vaccination.  On 22-Sep-2021 the patient developed a non-serious arm pain (pain in extremity) on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome of the event was unknown.  The reporter did not report the causality of event with suspect.  There will be no information available on the batch number for this case.
Pt recvd vax on 18AUG92 & on 20AUG92 pt devel ecchymotic area on rt forearm, roughly 1 1/4 inches in diameter; No further details were provided;
Whole Body itchiness with rash (Hives), Chest pressure with shortness of breath, chest tightness, malaise
On 8th day after getting vaccine, I noticed my deltoid was still very firm. I was pushing on it and showed my husband who also pushed on it. Within a few minutes, my throat felt tight, I began sweating and my nose completely clogged. I took ceterizine and benedryl and within 30-45 minutes began to feel relief. My nose was congested for approximately 8 hours after.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender who on 21-JAN-2013 was vaccinated subcutaneously with lot # (672476/1605AA exp date: 13-JAN-2013), 0.65 ml live ZOSTAVAX. No other co-suspects were reported. No concomitant medications were reported. The nurse stated that the patient did not had any adverse effects. This is one of several  reports from the same source. Additional information has been requested.
On 11/08/2022 Patient was administered a booster dose that had a of 11/02/2022.  Patient had no reports of adverse events.  Moderna was notified and stated the dose administered maintained the activity necessary to provide protection.
Site - back of (L) upper arm. (L) arm red with dark areas evident, pt. states that was where HEP B given. Pt. states sore & itches. MD assessed site & ordered antibiotics, advised pt. to wait to receive next HEP B for 2-3 months in (R) arm.
25 out of 8600 patients who recv flu vax using a needle free inj system manufactured by biotect devel inj site soreness;
Erythema and induration (R) anterior thigh. 5cm dia. Made him limp and hard to bear weight.
Moderna COVID-19 Vaccine EUA Tinnitus, left ear, moderate, still occurring 10 days later, following up with ENT
patient was given vaccine at local pharmacy on 7/30/21.  On 8/3/21, patient presented to ER for dyspnea.  Patient seen by PCP on 8/4/21 for hypertension.  Patient called the office 8/25 for Right leg pain that started several weeks ago, patient was advised to go to minor care.  Patient seen 8/26/21 at minor care for dyspnea, RT leg red/swollen  x 14 days.  Chest CTA ordered- showed Scattered bilateral pulmonary emboli. Venous u/s ordered- showed Extensive DVT.  Patient started on Eliquis 5mg.  Patient was seen by PCP for follow up on 9/2/21.  Next follow up appointment scheduled for October.
Was in office 6/16/04 and received (IM) tetanus and IPV (SQ) in Left arm. Pt returned on 6/18/04 with arm swollen, warm and red. Told pt to apply cold compress and use Benadryl until gone.
Patient received Shingrix vaccine and Pneumoxax 23 in left arm on 29 May 2019.  Patient contacted clinic on 04 June 2019 complaining of reduced mobility and "burning pain that radiates to his neck".   Conservative tx.  Seen by orthopedics 27 September 2019. Orthopedic surgeon dx patient with  Neuralgic amyotrophy post MRI.
INDIGESTION; LOSS OF APPETITE; NAUSEA; HEADACHES; FATIGUE; POSSIBLE EXACERBATION OF ALLERGIES; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included unknown allergies.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, expiry: UNKNOWN) dose was not reported, administered to right deltoid on 25-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced possible exacerbation of allergies. Treatment medications included: paracetamol. On 25-MAR-2021, the subject experienced headaches. On 25-MAR-2021, the subject experienced fatigue. On 26-MAR-2021, the subject experienced indigestion. On 26-MAR-2021, the subject experienced loss of appetite. On 26-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 30-MAR-2021, was recovering from headaches, fatigue, and indigestion, and the outcome of loss of appetite and possible exacerbation of allergies was not reported. This report was non-serious.
About 8 minutes after flu injection mother returned with client who was coughing, wheezing and face red. 10 minutes after injection evaluated by MD, Adrenalin 0.1 cc 1/1000 SQ. Evaluated by MD nebulizer treatment with xopenex 0.63 given. 20 minutes after injection (flu) Benadryl 25 mg PO. Admit to facility same day.   MR received from hospital for ER admit for anaphylactic reaction occuring within 30 minutes of flu vax.  Child initially began coughing and then had increased difficulty with breathing.  Child was brought back to pediatrician's office where he was given Benadryl and epinephrine and sent to the ER.  Upon arrival to the ED he was found to be wheezing. Txd with IV Benadryl, SoluMedrol, and H2 blocker and albuterol nebs PRN. Discharged in stable condition the next day. Discharge DX: Anaphylactic reaction to Influenza vaccine. 01/17/2007 PCP note received-no new MedDra codes.
Swollen and painful lymph node in left arm pit. Red and hot injection site diameter of softball on left arm. Night sweats and chills 11 hours after injection.
Loss of taste; This is a spontaneous report from a contactable other hcp. A 58-years-old no pregnant  female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in right arm on 19Feb2021 08:00 (Batch/Lot Number: EN6203) as single dose for covid-19 immunisation. Medical history included asthma, meniere's, hypoactive thyroid, syncope, allergies: Penicillin. There were no concomitant medications. No covid prior vaccination, no covid tested post vaccination. The patient experienced loss of taste (non-serious) on 20Feb2021 07:00 with outcome of not recovered.  The case is non serious.  Follow-up (14MAY2021): Follow-up attempts completed. No further information expected.
Pt started w/burning & itching of trunk approx 5 min p/inject; taken to ER ahd DPH & Celestone; @ ER pt had chest pain; no diff breathing;
High fever to 105.2, seen ER 5/15/07 WBC 6.9, 57% Neutrophil, 28% Lymph, urine and blood culture pending, CRP 8.9, Normal CXR
Patient vaccinated with Pfizer vaccine mixed with sterile water instead of 09% Normal Saline, preservative free. Consulted with advising organizations to determine next steps for patient after discovery. Re-vaccination advised and outreach team contacting impacted patient and offering to speak with a physician to discuss.
Diarrhea; Stomach pain; Was at end of period but flow has increased; This is a spontaneous report from a non-contactable consumer, the patient. A 45-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration on an unknown date (at the age of 45-year-old), as a single dose for COVID-19 immunisation. Medical history included allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received erythromycin (MANUFACTURER UNKNOWN) and metronidazole (FLAGYL), and experienced drug allergy. On an unknown date, the patient experienced diarrhea, stomach pain started about 4 hours after until 24 hours later. The patient was at end of period but flow had increased since about 24 hours after shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events diarrhea, stomach pain and was at end of period but flow had increased was recovering at the time of this report.   No follow-up attempts are possible. No further information is expected.
DTaP, MMR, Polio-Severe itchy, hives, wheezing, flushed appearance all over body approximately 15 minutes after injections.  Returned to office, albuterol NEB, pulse ok.  BP monitoring-Epinephrine, Dexaonstasone, Benadryl injections given.  Patient sent home on medications (Prelone, Benadryl, EPI Pen JR.
C/o joint and mucscle pain. Hurt all over back and legs hurt. Feet swollen.
Constant sweating; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Constant sweating) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Graves' disease.    On 12-Oct-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 HYPERHIDROSIS (Constant sweating). At the time of the report, HYPERHIDROSIS (Constant sweating) outcome was unknown.            No concomitant medications were reported.  No treatment information was provided.
SORE ARM; This spontaneous report received from a patient concerned a 62 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included seasonal allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1205A21A expiry: UNKNOWN) dose was not reported, administered on 12-JUL-2021 10:45 for prophylactic vaccination. No concomitant medications were reported. On 12-JUL-2021, the subject experienced sore arm. Laboratory data (dates unspecified) included: COVID-19 PCR test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from sore arm. This report was non-serious. This case, from the same reporter is linked to 20210728046 and 20210733974.
Administered hiberix without the diluent; Administered hiberix without the diluent; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Hib (Hiberix) (batch number 335N9, expiry date unknown) for prophylaxis.   On 26th April 2022, the patient received Hiberix. On 26th April 2022, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-May-2022 Reporter's Comments:  Registered nurse reported that, there were 3 vaccines that were administered hiberix without the diluent. She was unaware of how these vaccines were reconstituted so were unable to give any information. The reporter consented to follow up. Additional Supportive Information:  The patient received Hiberix without the diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR076035:Same reporter. US-GLAXOSMITHKLINE-US2022075751:Same reporter.
rash over entire body except face. fever, loose stools, headache and chills. fatigue.
ALLERGIC REACTION:  Hives, welts, fever 100.5, difficulty breathing, face/eye swelling for 5 days, muscle pain, cramping, difficulty walking. Predisone 50 mg daily for 5 days prescribed by Dr. for extreme allergic reactions.
sore throat, headache, cough, shortness of breath, body aches. starting 1/8/22
Polyarthralgia that began within 24 hours of second Pfizer dose that persisted for days. Patient reports residual joint pain in right elbow that has not yet resolved. Labs pending.
Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Error: Infection / Cellulitis (diagnosed by MD)-, Additional Details: rash, redness, some swelling and heat around injection site. unclear whether reaction to vaccine or cellulitis from improper injection technique . patient went to urgent care to obtain an antibiotic and has recovered.
Slight dizziness that has lasted almost a week. More frequent when bending down to standing up. Getting out of bed. feeling of pressure in the back of my neck that resonates up into the base of my skull and ears.
I felt my arm swelling were shot was put in my arm returned to store and was told to put ice on it now my arm is all bruised and pain in the left side of my neck same side the shot was done on. The shot was in my left arm.
had a pretty significant reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (had a pretty significant reaction) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (had a pretty significant reaction). At the time of the report, VACCINATION COMPLICATION (had a pretty significant reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.
Pt traveling. After receiving Yellow Fever vaccine, patient fainted & had a seizure. Seizure lasted approximately 15 seconds. Patient alert & responsive afterwards. IV fluids given & 911 notified.
Dizziness, weakness, redness, warmth at site. Redness about size of an orange and warm to touch on 09/12/13 when reported to Emp Health.
Rec'd 3 doses according to 0, 1, 2 months schedule. antigenemia occured following the third dose & resolved, without treatment.
2nd dose after 42 days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No medical history reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose after 42 days) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant medications have not been reported.  The patient will return to the country on 24-May-2021. His friend was inquiring about further actions.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 30Mar2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 14Apr2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "Allergies: Sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Skelaxin, reaction(s): "Allergy". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course patient received paxlovid as covid -19 treatment.  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 available information and the known product safety profile a causal relationship between the reported events, COVID 19, Drug Ineffective and BNT162B2 is considered possible.
The day after my vaccine I became really sick. Severe nausea, dizziness, headache, muscle aches and weakness. None of these symptoms have improved and now I have constant ringing in my ears that started this morning and has not stopped.
This spontaneous report was received from a nurse referring to 13 patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates, (reported as "between 09-SEP-2016 and 06-OCT-2016"), the patients were vaccinated with improperly stored dose of PNEUMOVAX 23 lot # M000592 and expiry date: 12-OCT-2017 (dose and route were not reported) for prophylaxis. The vaccine was exposed to temperature of 49 Fahrenheit for 30 minutes. No previous temperature excursion was reported. No adverse effects and no product quality complaint (PQC) was reported. No further information provided. This is one of several reports received from the same reporter. Follow up information has been received on 22-NOV-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information has been received from the Licensed practical nurse on 06-DEC-2016, who stated that a 68 year old patient was vaccinated on 06-OCT-2016 with a dose of PNEUMOVAX 23 (volume/dose reported as 0.5). Additional information has been requested. Sender's Comments: US-009507513-1610USA004378: US-009507513-1610USA004376: US-009507513-1610USA003097: US-009507513-1610USA004377: US-009507513-1612USA006597: US-009507513-1612USA006598.
One of nine cases: An event of Expired Drug Administered occurred in a 13 year-old  female. The report was received from a registered nurse. No medical or drug history was reported. The patient received a one-time dose of FluMist intranasally on 15-Jan-2008. On 15-Jan-2008, she received FluMist with an expiration date of 19-Dec-2007. The reporter stated this is one of nine children that was vaccinated on the same date. In discussing the error with two reporters from the site, they both indicated that the front of the FluMist box states "For the 2007/2008 Season", there is an expiration date on the side of the box. The reporter indicated they also administered a competitor's product, which is good for the entire season and does not expire until May/June timeframe. One reporter also stated many of the vaccines they give do not have an expiration date. She also indicated they do look for expiration dates, but it was confusing to have the front of the box indicate the vaccine was "For the 2007/2008 Season". The vaccination nurse at the site stated they placed the order for FluMist on 26-Nov-2007 for up 1 week later, and she was unsure why the site would be supplied with product that was to expire in less than weeks. Outcome: the child had ill effects, the site has not had any contact from  the child's family. Further dosing with FluMist is not indicated. Causality assessment is not applicable for this vaccination error. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Sore arm day after n for 3 days. On day 5 after shot; severe cough, sore throat, headache, fever, extreme fatigue and severe back back and stiff neck. Day 6 after shot migraine continues, severe back pain, ear ache, and stiff neck  fever through night.