chrisvoncsefalvay/vaers-outcomes huggingface dataset:
losing my hair a lot/ hair is falling out/ huge bald spot; body aches; tired; sore arm; tracers in my eyes/see water squigglies in the air; This spontaneous case was reported by a consumer and describes the occurrence of VITREOUS FLOATERS (tracers in my eyes/see water squigglies in the air), ALOPECIA (losing my hair a lot/ hair is falling out/ huge bald spot), MYALGIA (sore arm), MYALGIA (body aches) and FATIGUE (tired) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced VITREOUS FLOATERS (tracers in my eyes/see water squigglies in the air) and MYALGIA (sore arm). On 19-Aug-2021, the patient experienced MYALGIA (body aches) and FATIGUE (tired). On an unknown date, the patient experienced ALOPECIA (losing my hair a lot/ hair is falling out/ huge bald spot). At the time of the report, VITREOUS FLOATERS (tracers in my eyes/see water squigglies in the air), ALOPECIA (losing my hair a lot/ hair is falling out/ huge bald spot), MYALGIA (sore arm), MYALGIA (body aches) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
pt came in to have me look at bruise on arm. Large bruise roughly 3 by 4 inches has developed. pt denies falling or hitting arm. pharmacist who gave shot remembers that it bleed when gave shot. Pt denies taking warfarin or other blood thinners. No redness warmth or swelling to the touch. pt states small deposit under skin but I couldn't feel it. Recommended that pt follow up with doctor about why it bled so much.
local erythema, tenderness, swelling spanning from site of injection at the left deltoid region to ~2cm above the elbow in the left upper arm. no systemic signs/symptoms
This is a spontaneous report from a non-contactable physician. A patient of an unspecified age, gender and ethnicity was administered 3 doses of PREVNAR and a fourth dose of PREVNAR 13 on unspecified dates. The patient's medical history and concomitant medications were not provided. After conducting an assay on an unspecified date, the physician noticed that the patient was only fully immune to 1 of the 13 serotypes. Clinical outcome is unknown. No follow-up attempts possible. No further information expected.
A dose of Moderna 0.5mL given IM vs Moderna 0.25mL for booster.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 82 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Fever of 100.4-100.5, body aches, fatigue - lasted about 5 hours. Body aches continued overnight and around 13 hours post vaccine experienced diarrhea for several hours.
Within 3 mins client experienced spots, sweating. Post awareness, and had seizure-like Sx ie mouth movement and arm movements lasting < 10sec.
Covid break through case: I received my 2nd booster shot on 04/15/2022. My adverse event started on 05/07/2022 in the afternoon with a sneezing, coughing, really runny nose and I was also very tired. I tested positive for COVID on 05/08/2022. I called my doctor and he prescribed Paxlovid for 6 days. I recovered with the medication.
fever; chills; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pyrexia (1st dose received on an unknown date, refer case US2021AMR260504).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and chills. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the fever and chills were unknown.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced fever and chills. The patient commented that it sounds good compared to what he/she was reading. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR260504:Same reporter, same product, same patient, case for different dose
Partial loss of smell; Partial loss of taste; Things smelling bad that normally smell good; Things taste bad that normally taste good.; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 09Apr2021 at 12:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included ulcerative colitis and COVID-19; both from unknown dates. Concomitant medications included mesalazine (APRISO), azathioprine (IMURAN), prednisone (MANUFACTURER UNKNOWN) and cetirizine hydrochloride (ZYRTEC); all taken from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 19Mar2021 at 12:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Apr2021, the patient experienced partial loss of smell as well as things smelled bad that normally smelled good and partial loss of taste, and things tasted bad that normally tasted good. The clinical outcome of the events partial loss of taste, and things tasted bad that normally tasted good and partial loss of smell as well as things smelled bad that normally smelled good was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
I knew I was going to have a sore shoulder because that was consistent with my first shot. New symptoms were the pain at the injection site went down to my armpit area, was swollen and sensitive to touch, I had chills, sluggish, tired, felt like I was moving in slow motion. As if I had the flu. I called the nurse line and they said to get rest and if things don't improve in a few days to call the doctor.
Temperature 104 rectally; gave Tylenol. Complained of back itchy (spread to belly from back); Benadryl given. On 12/6/02, patient's mother reported rash completely resolved with no other side effects reported.
Chills, arthralgia, myalgia, fatigue, nausea presented rather rapidly in the early evening  of 12/31/2020.  A headache soon started. These symptoms continued until 1/2/2021 and were managed with max doses of IBU and APAP.  On 1/2/2021 a small rash appeared on my right deltoid at the injection site
significant pain in my joints; weakness; neck wrist, feet/ankle, shoulders popping; extreme fatigue for approx 5 months. Treatment was anti inflammatory medication and ADVIL (without success). I did not see a physician but I should have,
After receiving a Covid booster in my left arm on 10/18/2021, I developed a swollen lymph node under my left armpit which became noticeable on the afternoon of 10/19/2021. The area does not hurt to the touch but is considerably swollen compared to my right armpit. I also felt minor body aches, but those aches were not nearly as severe as my reaction to the second Pfizer dose I received on 04/02/2021.
powdered portion was mixed with a sterile water diluent rather than the DTap-IPV component with no adverse event; powdered portion was mixed with a sterile water diluent rather than the DTap-IPV component with no adverse event; Initial information received on 10-Jan-2023 regarding an unsolicited non-valid non-serious case received from a other health professional.  This case involves a patient of an unknown age and gender and reporter reported powdered portion of Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine [Pentacel (Vero)] was mixed with a sterile water diluent rather than the dtap-ipv component with no adverse event.  It is unknown if the patient had any medical history, concomitant disease or risk factor.   The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine Suspension for injection (with an unknown strength, lot number and expiry date) via unknown route in unknown administration site for Prophylactic Vaccination (Immunisation).  On an unknown date, reporter reported powdered portion Diphtheria/Tetanus/5 Hybrid Ac Pertussis/Ipv(Vero)/Hib(Prp/T) Vaccine was mixed with a sterile water diluent rather than the dtap-ipv component with no adverse event (product preparation error) (incorrect product formulation administered).  It is unknown if the patient experienced any additional symptoms/events.   It is unknown if there were lab data/results available.  It was reported I have replied to customer asking for lot, date of incident, and age of patient. No response at this time. I also directed them to call Medical Affairs. Copied original email from customer below #79934474 "Good afternoon , Last week we had a med error occur with a VFC provided Pentacel. I need to know whether Hib was effectively reconstituted or should be considered invalid. The parent has been notified by the NP of our error. I realize this is a VFC immunization rather than private stock, which removes this from your realm of responsibility. Was the company suspect product inappropriately used as per local Marketing authorization: Unknown    Action taken: not applicable.  Outcome: Unknown   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.
DEATH; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. The reported called for an agency, during call she had mentioned "several deaths were reported with the vaccine". She read it on a website. The cause of the deaths was not reported. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: 20210350272-covid-19 vaccine ad26.cov2.s-Death. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
I tore some chest and back muscles from severe coughing; Very exhausted; weak; Cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient received BNT162b2 (BNT162B2), on 25Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 72 years intramuscular, in arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "stomach acid" (unspecified if ongoing); "Type 2 Diabetes" (unspecified if ongoing). Concomitant medication(s) included: ENALAPRIL oral taken for hypertension (ongoing); IMIPRAMINE oral taken for depression (ongoing); PANTOPRAZOLE oral taken for hyperchlorhydria (ongoing); METFORMIN oral taken for type 2 diabetes mellitus, stop date: Mar2023. Vaccination history included: BNT162b2 (Dose: 01, Lot number: ER8727, Anatomical site of injection: L. Arm, Route of administration: Intramuscular), administration date: 23Mar2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 02, Lot number: ER8731, Anatomical site of injection: Arm, Route of administration: Intramuscular), administration date: 13Apr2021, when the patient was 71-year-old, for COVID-19 Immunization; BNT162b2 (Dose: 03, Lot number: FG3527, Anatomical site of injection: Arm, Route of administration: Intramuscular), administration date: 22Nov2021, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset Oct2022, outcome "unknown"; MUSCLE RUPTURE (medically significant), outcome "unknown", described as "I tore some chest and back muscles from severe coughing"; FATIGUE (non-serious), outcome "unknown", described as "Very exhausted"; ASTHENIA (non-serious), outcome "unknown", described as "weak". The patient underwent the following laboratory tests and procedures: X-ray: No Pneumonia, notes: had 2 X-rays.  Clinical course: Patient started enalapril, imipramine, and metformin 20 years before. She developed a serious cough in Mid Oct2022, so severe that she tore some chest and back muscles from severe coughing. Patient had 2 X-rays but no pneumonia. Patient was very exhausted and weak from this. Patient did not know if it was RSV, not diagnosed as such. Patient talked to friends and relatives in (Name withheld) who described identical cough, relentless. Patient had 5 Pfizer vaccinations/boosters.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300039609 same patient, different vaccine doses/event;
Dizziness and bad vertigo - ongoing since 4/29, the day after the 2nd dose.
Entire thigh swelling on side where PCV-13 was administered. Also erythema and warmth.  No fevers. Admitted to Hospital for possible cellulitis on 1/1/2010, discharged 1/3/2010.
This spontaneous report was received from a Registered Nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date, the patient was vaccinated with improperly stored VARIVAX, lot # R002054 and expiration date on 22-JAN-2018, for prophylaxis (route of administration and anatomical location were not reported). It was reported that the vaccine was reconstituted with properly stored sterile diluent. The administered dose of the vaccine experienced a temperature excursion of -9 to 8 degrees Celsius for 2 hours and 47 minutes, as recorded by a data logger. The vaccine had not had any previous temperature excursions. There was no adverse effect reported. No product quality complaint was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1810USA012270: US-009507513-1810USA012268: US-009507513-1810USA012269.
Fever of 101, extreme unusual exhaustion (14 hours of sleep), nausea, chills, sweating
I just had a pacemaker put in; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC PACEMAKER INSERTION (I just had a pacemaker put in) 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.    In May 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2022, the patient experienced CARDIAC PACEMAKER INSERTION (I just had a pacemaker put in). At the time of the report, CARDIAC PACEMAKER INSERTION (I just had a pacemaker put in) outcome was unknown.            The concomitant medication was not reported by reporter. Patient enquired that will it hurt to get 5th booster because patient just had a pacemaker put in, the date was 18-Aug-2022. Patient's last booster of Moderna was May-2022. The treatment medication was not reported by reporter.
I started to have muscle twitching under my left eye first. But now I have muscle twitching in my eyebrow as well. So I am experiencing muscle twitching under my left eye and above my left eye in my eye brow.
Parent was not able to hold child on exam tablet very well. I was holding legs and gave mom the job of holding hands well. Patient is very active and was not happy laying flat. I went to take off cap and inject vaccine, parent was not holding enough and patient rolled away from vaccine. After noticing patient rolling away, needle came out and vaccine was spilled onto table paper. Patient did not receive full dose, maybe not even half the dose. We repeated vaccine and had an additional nurse come in and help hold legs. Second attempt was successful and patient did in fact receive entire dose of vaccine.
pt recv vax 8NOV96 430PM & pt states in 24hr site of inj swollen & sl sore w/small blisters over inj site;went to MD office for f/u visit on medical illness 10NOV96 & was treated w/ATB;21NOV96 to MD site healing w/scabbing;
fever; headache; a red knot that was hot and sore to the touch; a red knot that was hot and sore to the touch; a red knot that was hot and sore to the touch; slept for 36 hours; This is a spontaneous report from a contactable Nurse (Patient) via Pfizer Sales Representative. A 66 (unit: unknown) female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 19Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The Patient had previously received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 26Feb2021 as a single dose for COVID-19 immunisation. On an unspecified date, it was reported that Female 66 had a local reaction. It was a red knot that was hot and sore to the touch. She also developed a fever and headache. She slept for 36 hours. the reporter of the adverse events and she was the patient. She is a retired nurse. Her first COVID vaccine was on 26Feb2021, and her second vaccine was on 19Mar2021. If you need any additional information, please let me know. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Numbness on left hand/arm.  Paresthesias and Numbness on left hand/arm  for 3 weeks after vaccine was given
Patient received the vaccine. During the 15 minute observation period she developed chest heaviness, arm tingling, and throat tingling. BP elevated at 169/79. The patient was sent to the ED and evaluated. Diagnosed with more anxiety type symptoms. Discharge from ED stable.
On day of shot, area below shot on arm and continuing to elbow became red and itchy with some large lumps.  Thereafter, to date (one week after shot administration) have developed small numbers of hives each day on various parts of the body, but primarily on face, ears and scalp.  Have taken benadryl and other diphenhydramine products to reduce itching.  Am surprised the reaction has continued this long and has not yet stopped.
low grade fever inconsolable crying, extremely, irritable, complete change in personality for 24 hours
pt son vax on 29JUL98, on 19AUG98 pt devel ``sx consistent w/ the mumps virus'', swollen, tender parotid glands & dry mouth. blood tests revealed elevated amylase, otherwise norm. f/u indicates pt condition ``felt now to be unrelated''
Approx 5 hours after administering vaccine, patient called lead NP and reported swelling of upper eyelid and lower lip as well as body aches. Patient is NP and reported he will take 50mg of BENADRYL. Will follow up patient.
It started with transient joint pain, hands, knees, and feet. Developed severe pedal edema. Within 2 weeks, I went from being active and able to do most anything, to not being able to do anything. Was prescribed Advil and topical pain ointment. Did nothing. Sept. 7, prednisone was prescribed. It helped with inflammation, but when I came off, it came back faster and worse than ever. Saw rheumatologist on Nov. 1.  He said he'd never seen RA come on that fast. 8/23 ANA and RA negative. 10/1 RA 236.8.
I developed a rash on my left arm about an inch below the injection site on January 18th 2021, 11 days after receiving the first dose of the covid vaccine. It was about the size of a nickel and the next day it grew to the size of about an inch tall and two inches wide. It was warm to the touch and splotchy. The next day it grew to about the size of the diameter of a sofa can and started itching. I had gone to the doctor the second day of the rash and they suggested that I get a covid test, which came back negative, and to put heat on it and some antibiotic ointment on it and watch it. I called the doctor the next day because it grew and was now itchy. I also had an itchy mouth. The doctor suggested that I take an antihistamine twice a day for 7 days to see if that helps. I started this last night, January 20 2021. Today is the 4th day, the rash has not grown and is no longer itchy and my mouth is no longer itchy.
Sinus congestion, cough, sore throat aches on day of injection. Reported to pharmacy 10/18/13.