chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a mother regarding her 11 year old son who experienced fever.  At 11 years of age, the pt received a dose on 12/18/03.  The pt had sinusitis, cough, and congestion when he received the Flumist.  The physician began therapy with amoxicillin on 12/18/03, since the pt's nasal discharge had changed from clear to yellow.  The pt's medical history also included attention deficit/hyperactivity disorder.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 12/18/03.  Dose regimen was 1 dose (IN).  Concomitant therapy included Ritalin (methylphenidate hydrochloride) and amoxicillin.  The pt began "spiking" a fever (pyrexia) of 101-103 deg. F., on  12/19/03.  The mother stated that Tylenol (acetaminophen) "does not seem to help the fever very much," and ibuprofen helped more, "but you can tell when it wears off."  The mother reported that the pt's cough and congestion were "about the same" as before he received Flumist.  No additional information was available at the date of this report.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015 18:06, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.2 and 1.6 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
After I got my shot around 1:00 am in the morning.  I started feeling fatigue and chills. Had server joint pain that lasted for 12 hours.
This case was reported by a physician via sales representative and described the occurrence of vaccination failure in an unspecified number of subjects of unspecified ages and gender who were vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of ROTARIX (unknown) and experienced vaccination failure. The physician reported "problems with ROTARIX, to include ROTARIX failures". This case was assessed as medically serious by GSK. Follow-up information was received on 26 April 2010, via physician who reported I did not have a patient who suffered an adverse event". No other information was provided.
HAS HAD A BAD RASH ALL OVER HIS BODY FOR 5 DAYS NOW... BENADRYL HASN'T HAD AN EFFECT
C/o shaking, thrashing his body on the floor, kicking, wouldn't walk - only crawl. Was frightened of mom. Wouldn't let mom hold him. Symptoms lasted x 2 hours.
Patient received the shot on Saturday and on sunday she developed severe pain and soreness at the injection site. Three days later on Thursday she noticed a red bump and it was warm to touch. On Thursday 05/09, she was advised by the pharmacist to take Benadryl 50mg. She did but it did not help. She called back on Friday and said it was not getting better. I told her to try taking Ibuprofen for pain and inflammation. Also advised her to see her doctor if it does not improve in a few days or if it gets better. Patient denied having any shortness of breath or any other symptoms other than localized reaction.
Patient with cardiogenic shock due to severe myo-pericarditis, severe inflammatory response with high fever up to 104. Cardiogenic shock requiring placement of Impella support.
MOC reported that entire thigh was red & swollen; Child had a high pitched cry for 2 hrs; No known fever;
Patient reported that for about a week after the injection she had pain and decreased movement in left shoulder with mild tenderness at point of injection. Patient reports going to an Urgent Care with no MRI ordered. Reports improvement of ROM but still has pain. Made an appt with ortho. Stated she did not follow up sooner for medical care because she said she is a busy lawyer and did not have time to call. Offered follow up in the clinic and suggested treatments of NSAIDS OTC and warm compresses but does not wish to go this route. Attempted to have ortho appt moved up for patient and gave the patient the available ortho times.
In arm where pt received TDaP and PNEUMOVAX the arm became really red and swollen, said doing better on Monday and taking MOTRIN. On Tuesday 10 AM, said going to MD to get something to bring swelling down. Described it as a large red band around his left arm.
Could not get out of bed after the first booster shot; Nausea after the first booster shot, Did not know what day it was after the first booster shot; Sugar was out of range after the first booster shot; Had 5 blankets on her after the first booster shot; Could not eat after the first booster shot; This spontaneous case was reported by a patient and describes the occurrence of BEDRIDDEN (Could not get out of bed after the first booster shot), NAUSEA (Nausea after the first booster shot, Did not know what day it was after the first booster shot), BLOOD GLUCOSE ABNORMAL (Sugar was out of range after the first booster shot), FEELING ABNORMAL (Had  5 blankets on her after the first booster shot) and DECREASED APPETITE (Could not eat after the first booster shot) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031C21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, the patient experienced BEDRIDDEN (Could not get out of bed after the first booster shot), NAUSEA (Nausea after the first booster shot, Did not know what day it was after the first booster shot), BLOOD GLUCOSE ABNORMAL (Sugar was out of range after the first booster shot), FEELING ABNORMAL (Had  5 blankets on her after the first booster shot) and DECREASED APPETITE (Could not eat after the first booster shot). On 07-Nov-2021, BEDRIDDEN (Could not get out of bed after the first booster shot), NAUSEA (Nausea after the first booster shot, Did not know what day it was after the first booster shot), BLOOD GLUCOSE ABNORMAL (Sugar was out of range after the first booster shot), FEELING ABNORMAL (Had  5 blankets on her after the first booster shot) and DECREASED APPETITE (Could not eat after the first booster shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Nov-2021, Blood glucose: sugar was out of range.    No concomitant drug were reported.   No treatment drug were reported.   This case was linked to MOD-2022-660474 (Patient Link).
102.4 degree fever; severe chills; moderate fatigue; moderate headache; moderate muscle pain; mild pain at the injection site; This is a spontaneous report from a contactable 30-year-old female consumer reported for herself. A 30-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6201) via an unspecified route of administration in left arm on 12-FEB-2021 08:30AM as 2ND DOSE, SINGLE for covid-19 immunisation. Medical history includes major depressive disorder and generalized anxiety disorder. The patient previously took first dose of bnt162b2 on 22Jan2021 at 05:45 pm (Lot #EL9262) on Left arm, for covid-19 immunisation. Concomitant medications within 2 weeks of vaccination included lexapro, ibuprofen, acetaminophen, diphenhydramine. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the same date of vaccination at 08:00 PM she had 102.4-degree fever, severe chills, moderate fatigue, moderate headache, moderate muscle pain and mild pain at the injection site. No treatment was received for the adverse event. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Known allergies to medications, food, or other products were none. The clinical outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Pt recvd 3 Engerix-B vax on 0,1,6 mo schedule.04JAN91 titer indicated little response.
Patient presented to the office 10 days after receiving MMR vaccine with c/o head-toe rash. Patient was also currently being treated for AOM and taking Amox. It is unknown whether a reaction form vaccine or Amox.
Due to Covid-19 lockdown the patient has not been able to receive the second dose.; This case was reported by a pharmacist via call center representative and described the occurrence of social problem in a 83-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1s dose received on 12th December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that, due to Covid-19 lockdown the patient had not been able to receive the second dose of Shingrix, which led to social problem.  The reporter consented to follow up. This case was 1 of 5 linked cases, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021199882:same reporter US-GLAXOSMITHKLINE-US2019AMR161146:same reporter US-GLAXOSMITHKLINE-US2019AMR157845:same reporter US-GLAXOSMITHKLINE-US2019157535:same reporter
New onset erythema and induration at injection site 7 days after vaccination.  Site measures 7 x 5 cm
day of vax sick, hurting, nauseous, arm hurting @ inj site;
Single episode seizure (no prior history of seizures), witnessed by wife. Seizure consisted of thrashing around with foaming at mouth middle of night.  EMS found postictal with gradual clearing of senses. No residual symptoms after time in emergency department. Discharged by afternoon of the same day with levetiracetam 750mg BID (500mg tabs 1.5 tabs BID).
Information has been received from a nurse concerning a female who was vaccinated with GARDASIL vaccine. It was unknown how many doses of GARDASIL vaccine the patient had received. The patient who had a normal PAP prior to vaccination had an abnormal PAP and was positive for HPV. At the time of this report, the patient was not recovered. The patient sought unspecified medical attention at office. No further information is available.
This spontaneous report as received from a health professional refers to a 15 month old patient. On 16-MAY-2014 the patient was vaccinated with VARIVAX (Merck) (lot # J012377, expiration date 03-OCT-2015, dose and route not reported) which was stored improperly. There was no adverse effect reported. This is one of several reports received from the same source. Additional information is not expected.
Death N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified
7/28/21 @ 4 pm  Nausea and shoulder/neck muscular pain 7/28/21 - 7/29/21 Restlessness throughout night, nausea, muscular pain 7/29/21 @ 630 am - Vomiting 7/29/21 @ 9 am Fever - 100.4 F 7/29/21 all day - muscle pain, fatigue, loss of appetite 7/30/21 - fever,  pain , fatigue all resolved 8/2/21 - neck and upper back muscle pain
no anitbodies for measles; received vaccination before she was 1 years old; This spontaneous report was received from a patient's husband and refers to a currently 65-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, before the patient was 1-year-old, she was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. On an unknown date, the patient got her "titers pulled" and it showed no anitbodies for measles. The outcome of the event was unknown. The causality assessment between the event and the suspect vaccine was not provided.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Sep2022 as dose 3 (booster), single (Lot number: GN2524) at the age of 62 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Colitis ulcerative" (unspecified if ongoing), notes: Colitis ulcerative. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient had receive COVID-19 Vaccine previously. Patient took Paxlovid from 08Nov2022 to 12Nov2022 for the treatment of COVID-19.
Complaint of headache following vaccine administration at 2:25. States she is fine, headache is almost completely gone at 2:30 BP 90/60 apical pulse 78. No further complaints.
103.9 fever, chills, shaking, chattering teeth, full body pains and aches, I was unable to move I was in so much pain, fluid in ears felt like boiling wax. Very sore arm of injection site. Fever took 12 hours to break but then came back on 11/25/21 at 11am. Currently taking ibuprofen and Tylenol every 4 hours and fever is is at 101.1 right now. I only had a sore arm with the first two shots, something isn?t right with this one or this lot.
Narrative:  68yo male with hx of CVA & DM resided in nursing facility died on 8/9/2021. No information regarding pt's death provided. Pt had received only one moderna covid vaccine.on 4/17/21. Likely death not related to vaccine due to length of time btwn death & vaccine administration date.
pt recv vax;lt arm hurt where shot given;lt arm red,hot,swollen fr shoulder below w/hard lump at inject site;fever next am;lower arm & hand turned blue,lost feeling in it,lasted short time;felt weak & faint;chill when cool cloth use;to MD
Shortness of breath, chest pain that feels like a heart attack, rapid heart rate, headache, muscle fatigue and extreme tiredness
Started vomiting on 09/21/13, developed a fever 09/22/13 and on 09/23/13 fever of 100.6 F and chills. 9/23/13 pt took TYLENOL in the morning and when pt was called back at 11 AM she felt better and fever had broke.
Patient called to report complaint of right arm/shoulder pain starting the evening of vaccine that intensified and was accompanied by high fever over the next 8-9 days. She went to the ER 11 days after vaccine and they referred her to an orthopedic doctor since she was still having severe pain, muscle tightness and loss of motion due to the pain. She was given steroid shots and had physical therapy, but says she is still having issues - still having pain, spasms and decreased motion which are not as bad as they were, but still lingering so she wanted to report her symptoms.
rash over trunk and extremities.  Treated with Triamcinolone Acetonide Cream, and sun exposure. Rash resolved.
Lesions right thigh local redness from shot area with some minor ecchymosis - no d/c not warm or hot to tough, slightly raised - there is also a red raised rash /patch top of hip posterior, some minor crusting on top, slight yellow without oozing, color & pigmentation were normal.
Patient received the 4th dose (2nd booster), then said after an hour her arm started to hurt. She went to dermatology on 7/28 for something unrelated. The MD prescribed an antibiotic.
Patient had severe hypoxia and hypotension, arrived to the hospital on 11/25/21, was intubated,  and died 8hrs later.
Flu-like symptoms, chills, feverish, through night and recovering the next day. Unable to operate full activities, some time in bed. Recovered mostly by 36 hours after injections.
Hives covering entire body, extreme swelling of skin, itchiness, inflammation. Followed by extreme joint paint and inflammation-could not walk or use joints. Fever. Treated with cortisone, steroid tablets, Zyrtec, and Benadryl. Missed entire week of work.
achy arm, very sore; feeling hot/cold; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (achy arm, very sore), FEELING OF BODY TEMPERATURE CHANGE (feeling hot/cold) and HEADACHE (headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (achy arm, very sore), FEELING OF BODY TEMPERATURE CHANGE (feeling hot/cold) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (achy arm, very sore), FEELING OF BODY TEMPERATURE CHANGE (feeling hot/cold) and HEADACHE (headache) outcome was unknown.            No concomitant medications were provided.    This case was linked to US-MODERNATX, INC.-MOD-2021-042996 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-042996:MOD21-051913
Injection site became very itchy , red, slightly painful, and hot, 11 days after vaccine was given.  Next day itching mostly went away, but still red in a triangular shape, about 2" by 3" in, and still warm.  Today, two days later, redness has greatly dimished, but still discolored.
pt recv vax 9MAY95 & 18MAY95 pt devel 7 chicken pox-like lesions; No further details were provided;
expired dose of ADACEL was administered with no reported adverse event; Initial information received on 14-Aug-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 26 years old female patient to whom expired dose of adacel was administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 13-Aug-2023, the patient received 0.5 ml (dose 1) of suspect diphtheria-2/tetanus/5 AC pertussis vaccine, Suspension for injection lot C5921BA, expiry date: 29-Jul-2023 via intramuscular route in the left deltoid for immunization (strength unknown), expired dose of adacel was administered with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered  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 the 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 interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
The first sign was three days after my first dose which was received on 08/24/2021.  Symptom consisted of palpitations with very rapid and pounding heartbeats (twice that same day).   My Severe adverse event happened the same day of my second dose, roughly five hours following.  Spontaneous pounding heart, very rapid heart rate over 130 bpm while I was just sitting in class.  I had trouble trying to breathe and focus, nauseous and I thought I  was going to die. These events would happen once every 3-5 days for the next 3-4 weeks.
Pt received Pfizer dose to right deltoid. Pt previously received moderna first dose 4/1/21. Pt denies any signs and symptoms of adverse affect. Pt observed 30min post injection, given information on reporting to state health services. VAERS filed for incident by SEPOD vaccination charge. Pt educated on signs & symptoms of severe adverse reaction & when to seek medical care upon exiting POD. Advised pt to contact AZDS for advice on vaccination status. Pt left in POV on own accord.
Migraine & sinus pressure, large welt from injection site to shoulder, non-centralized arm pain, body aches, joint aches
Dizziness and  vertigo began the next night when I laid down and again when I got up. It passed and did not recur that night. Episodes continued randomly at night. Got treatment for BPPV on 03/24. No symptoms until 04/05 when I had one episode overnight. Recurred 04/07 at 2:15 am. This time it has not subsided and it is 10:30 am. I wonder what to do next?
Skin became red, puffy, itchy, and inflamed around entire body.   Rashes appeared all over body as well.
first 10 minutes, she developed rash and heating sensation on her face. after 10 mintues, the rashes and heats moved throw out her body. she mentioned that she felt dizziness and little hard to breath for a short period (went away a few minutes later). We had her stayed, watched her and gave her benadryl.   After an hour, she said she is okay and went home.  We followed up with her the next day, 3/18, she was fine but the rash was still there.
Cardiac arrest with no symptoms. Patient had no previous symptoms. Cardiac arrest that led to death.
Systemic: Chills-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild, Systemic: Hypotension-Mild, Additional Details: 16 years old male suddently have low blood pressure, light headache, not feeling well, gave him a dose of tylenol 500mg, a bottle of water, and call 911.
Vaccine was given from a vial that was punctured at 4:55pm on 8/31, so it was considered expired at 4:55am on 9/1.  Vaccine was given from this vial at 10:33am on 9/1.
pt recv vax 18NOV98 & 19NOV devel nausea, tremor, wheezing;
Vx administered after a temperature excursion; This case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 70-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 29th November 2021, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided are as follows: The reporter reported that a patient received a dose of Boostrix had suffered a previous temperature excursion and was later administrated, which led to incorrect storage of drug. No further events were reported. The reporter agreed to be contacted for follow-up. This case has been linked with case US2021AMR257658, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR257658:Same reporter
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 12-MAR-2019, the patient was vaccinated with M-M-R II (strength and dose were not reported; lot # N020926 and expiration date 01-AUG-2019) which was reconstituted with sterile diluent intramuscularly rather than subcutaneously for prophylaxis. No adverse effects were reported.