chrisvoncsefalvay/vaers-outcomes huggingface dataset:
slightly more swelling about just it hot; slightly more swelling about just it hot; muscle pain from another shot was given in right arm through the armpit to the right boob; muscle swelling; was difficult to sleep; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of  bnt162b2 (BNT162B2, Lot Number: EW0162), via an unspecified route of administration on 15Apr2021 08:45 as single dose for COVID-19 immunisation. The patient's medical history was not reported. The patient had no other products. The patient previously received first dose of bnt162b2 (lot number: ER8733, expiration date: 31Jul2021) on 25Mar2021 08:30 for covid-19 immunisation, and experienced 3 inch diameter of a red hot slightly swollen area last for about 3 days. The second shot 3 weeks later and same reaction slightly more swelling about just it hot but it lasted almost 5 days. However, with the second shot she had a muscle pain from another shot was given in right arm through the armpit to the right boob and now, she had been subsided until today which was almost day 6th and it was terrible that pain in the muscle swelling was just the first two days was difficult to sleep and she was just curious if anyone else has this muscle pain that from the short area through the armpit in to the right chest area in to the right boob. Treatment received Tylenol and Ibuprofen for the pain from second shot. The outcome of events was unknown.  No follow-up attempts are needed. No further information is expected.
Feeling faint, light-headed followed by rapid heart rate.  Feeling cold, perspired.  Vitals were taken by EMS on-site.  Immediate symptoms subsided within 10-15 minutes.
Started with minir pins and needles in left forearm a few weeks after vaccine. Gradually getting worse until one night shooting paresthesias eventually hetting so bad it went in to my left jaw, cheek , top of left ear and top of head. Ultimately it also went into foot and I was unable to have fine motor use in left hand especially thumb. I had multiple ER visits, doctors visits MRI and ct scan of head and see a neurogist. 5bday course of prednisone helped stoped all symptoms but when stopped taking had a rebound effect.  The worst symptoms last a month. Now it comes and goes i intermittent.
MIGRAINE / HEADACHE; FEVER; BODY ACHES; This spontaneous report received from a parent concerned an 18 year old female. 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: 042a21a, and expiry: UNKOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported.  On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced fever. On 16-APR-2021, the subject experienced migraine / headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, and fever on 09-APR-2021, and the outcome of migraine / headache was not reported. This report was non-serious.
Drug dose administration interval too long; Fever; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long) and PYREXIA (Fever) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long) and PYREXIA (Fever). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Drug dose administration interval too long) outcome was unknown and PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No Concomitant medications were provided No Treatment information provided
pt recv vax 23OCT96 @ 830AM;@ noon same day felt cold & devel shakes;returned to clinic 7AM next AM w/rigors & temp 101.4;sent to hosp adm to r/o sepsis;had nl WBC & all cult negative;initially w/mild hypotension responded quickly to
Patient has developed a bruise on her right deltoid that developed the night the vaccine was given on 10/8/21 and continues to persist on 10/26/21.
3/23 mild headache 3/24 mild headache 3/25 mild headache 3/26 rash started, in patches, right arm, trunk, under hair on head, and partially down back of neck.Severe itchiness. Took OTC benadryl, two tablets, no relief. 3/27 rash continues, itches more in evening
has been on med protocol for MS; This case was reported by a consumer via interactive digital media and described the occurrence of multiple sclerosis in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (patient's brother had shingles and lasted for a few months).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced multiple sclerosis (serious criteria GSK medically significant). On an unknown date, the outcome of the multiple sclerosis was unknown.   It was unknown if the reporter considered the multiple sclerosis to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient's sibling. The age at vaccination was not reported. The patient took the Shingles vaccine and she was fine although she had been on med protocol for MS (Multiple sclerosis). The reporter stated that everyone would be different and needed to make their own decisions. The follow-up would not possible as no contact details were available. This case was linked with US2021AMR199698 and US2021AMR199709, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR199698:Same reporter US-GLAXOSMITHKLINE-US2021AMR199709:Same reporter
Severe Headache, Vomiting, Lymph node swelling in left arm Took tylenol and Meloxicam-little relief from symptoms
Onset 8/18/06 in arm, redness, pain around site of IPV and Dtap vaccines.
administer expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medication were not reported. Number of doses administered was 102 doses. The vial did not undergo any temperature excursions.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received with updated reporter details.
Patient stated that she felt pain immediately after the administration and that it has continued to worsen over the course of several hours. It is painful to move her neck and sholuders and cannot lift arm. It is centered around neck and shoulders and she describes it as a shooting pain.  She is currently taking ibuprofen and icing the area.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Pt recovered after a few minutes of sweating and feeling nauseous.
Kidney failure. Creatinine 8.59, previous 1.35 prior to booster.
Larger than normal dose administered. Patient monitored for 30 minutes post administration. called that evening for checkup and 24 hours post. patient reported feeling good.
red hot circle in the injection area; red hot circle in the injection area; administered first dose of Shingrix subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st September 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 21st September 2020, less than a day after receiving Shingrix, the patient experienced injection site erythema, injection site warmth and intramuscular formulation administered by other route. On an unknown date, the outcome of the injection site erythema and injection site warmth were not recovered/not resolved and the outcome of the intramuscular formulation administered by other route was unknown.   It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The reporter reported the physician administered 1sr dose of Shingrix subcutaneously, which led to intramuscular formulation administered by other route. The patient had a red hot circle in the injection area after the vaccination, which was not recovered till the time of reporting. The reporter did not consented to follow up.
Customer warned that he has a history of passing out during and/or after vaccination.  After administering the vaccination the customer was fine for a few moments and then silently stopped breathing and lost consciousness while eyes stayed wide open. After addressing the customer a few moments later the customer became responsive.
Initial unsolicited report received from a Nurse on 11-Jun-2018. This case involves a patient (age and gender not reported) who was vaccinated with a dose of IPOL (batch number, expiry date, dose, route and site of administration were not reported) instead of TUBERSOL (batch number and expiry date were not reported) on an unspecified date. It was a case of actual medication error due to wrong vaccine administered. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be 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. Documents held by sender: none.
This case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine at an unknown dose. On an unknown date, unknown after receiving dTpa vaccine, the patient experienced allergic reaction and erythema. On an unknown date, the outcome of the allergic reaction and erythema were unknown. It was unknown if the reporter considered the allergic reaction and erythema to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient asked about risk of reaction to SHINGRIX after she had an allergic reaction to a tetanus vaccine years before the reporting date. The pharmacist did believe the vaccine was a Tdap and not a tetanus vaccine alone. The pharmacist only knew the patient reported an allergic reaction and mentioned redness. The pharmacist declined to provide date of birth and additional questions noting she was not sure and would contact the patient's physician for direction. The serious criteria questions were not asked due to pharmacist not continuing with report. Only questions asked are those already documented.
Patient's lips started feeling tingly and she said her throat was getting sore - I gave her 50mg of diphenhydramine and had her wait an additional 20 minutes. She felt better at that time and her husband is a paramedic, so they opted to go home. I checked in with her later in the evening and she said she wasn't feeling better, but also not worse. I encouraged her to go to the ER with any worsening symptoms and to call her doctor the following day.
This spontaneous report was received from a consumer concerning an unspecified patient (demographics unknown). The patient's pertinent medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route and lot# not provided). The consumer reported that the patient was in process of diagnosis for autism spectrum disorder. At the time of the report, the patient's outcome was unknown. This is one of several reports received from the same source. Additional information is not expected, no contact details were provided.
Fever, severe agitation, eczema flareup.  Every day since (almost 3 years) symptoms continued to get worse.
(This case has been evaluated by agency) The pt. stated that he had received the SPV (primary) on 5/9/14 in his upper left arm. Additionally, he received a typhoid and AVA #1 on 5/8/14. The pt. was in his normal state of good health at the time of the vaccinations. The pt. reports that he has had constant, substernal chest pain (8/10) for 16 hours. He states that he applied "icy/hot" to his chest without improvement. The pain is made worse with lying down, taking a deep breath and leaning forward. The pain is improved when the pt. is in a "slouching" position. He denied SOB, radiation of the pain, diaphoresis, N, V or palpitations. The pt. reported that he basically had rested all day without improvement of his chest pain. He also related that the vaccination site was red, warm, swollen and tender and that the lymph nodes in his neck and armpit were also tender. The pt. was instructed to proceed to the ER for evaluation for possible myopericarditis. He was instructed to provide the ER staff with the number to the Cell Center so that a copy of the Clinical Guidelines for Post-Smallpox Vaccine Associated Myopericarditis could be provided. The pt. reported to Medical Center. His vital signs were stable 117/78, 73, 16, 98% SpO2; PE revealed: RRR, no murmur; Normal breath sounds, no respiratory distress/rales/wheezes, no chest wall tenderness. Labs showed normal Troponin T, BMP and CBC (see below). His also had a normal CXR and EKG (SR with ST elevation-probably early repolarization). The pt. was discharged with instruction to follow-up with his PCM on 5/19/14. This provider instructed the pt. to take MOTRIN 600-800 mg tid with food. Consulted with NP, provider on call. Requested that the pt. be evaluated with a repeat EKG, cardiac enzymes (Troponin I and CKMB), ESR, CRP and a possible echocardiogram (See note dated 5/18/14). The pt was seen at the Clinic on 5/20/14. The pt. reported "feeling better" but that his chest pain had not completely resolved - he complained of pain, N, V or diaphoresis. On PE it was noted that no murmurs, gallops or pericardial friction rub were heard. An ESR (wnl) and CRP (8.3H) were done. The EKG showed NSR with early repolarization. The pt. was placed on a light duty profile and given a medical temporary exemption for further vaccinations. The pt was seen by dr, cardiology and cardiovascular services, on 5/22/14. The pt. reported that the chest pain had resolved except for mild "epigastric and retrosternal chest tenderness". The PE was normal. The EKG showed NRS with diffuse ST elevation "most compatible with benign early repolarization. An echocardiogram was normal (EF 60%, no pericardial effusion) with the exception of mild mitral valve regurgitation. It was determined that the pt's chest pain was non-cardiac in nature; he was cleared to resume vigorous activity and to return to full employment.
Several days after receiving the vaccine, she reports her arm became swollen, red and hot below the injection site.
No adverse event; received the first two Moderna vaccines 6 months apart; This spontaneous case was reported by a patient family member or friend and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first two Moderna vaccines 6 months apart) and NO ADVERSE EVENT (No adverse event) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first two Moderna vaccines 6 months apart). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received the first two Moderna vaccines 6 months apart) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication were reported.  Patient received the first two Moderna vaccines 6 months apart way back in Jan 2020 or 2021. Patient received first dose of Moderna in January and second dose in July.       No treatment information was provided by the reporter.   This case was linked to MOD-2022-675040 (Patient Link).
Body aches, headache and fever up to 104.1 degrees taken orally.; Body aches, headache and fever up to 104.1 degrees taken orally.; Body aches, headache and fever up to 104.1 degrees taken orally.; This is a spontaneous report from a non contactable nurse.  A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EK5730), intramuscular on 11Jan2021 07:00 at single dose for covid-19 immunisation.  Medical history included Allergies, anxiety, depression.  Concomitant medication included sertraline, cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]). The patient previously took minocycline and experienced drug hypersensitivity. The patient received 1st dose of bnt162b2 on 21Dec2020 10:00 AM Intramuscular at Left arm.  The patient experienced Body aches, headache and fever up to 104.1 degrees taken orally. The outcome of the events was resolving.  No follow-up attempts are possible. No further information is expected.
SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINE FAILURE; This spontaneous report received from a physician concerned a patient of unspecified age and sex of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection (breakthrough infection) and suspected clinical vaccine failure and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccine failure was not reported. This report was serious (Hospitalization Caused / Prolonged). This report associated with product complaint number: 90000187772.; Sender's Comments: V0:20210758266 - Covid-19 vaccine ad26.cov2.s - Suspected Covid 19 infection. 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). 20210758266 - Covid-19 vaccine ad26.cov2.s - Suspected clinical vaccine failure. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Purplish rash that spread bilaterally to inner thighs while at work. Area felt cold but no itching. Took 600mg ibuprofen - rash resolved
Feb. 5th at approx. 730pm started feeling ill with muscle aches, chills, rapid heart rate, dizziness and temp. of 100.1. By 9pm had body shaking, bad headache, nausea, rapid breathing and fever of 102.0 that escalated to 103.2 by 1145pm, at which time, mild edema around eyes noted. Tylenol 650mg was taken every 4-5 hours starting from about 830pm that evening. Temp. at 615am Feb 6th was 102.6, at which time, Ibuprofen 200mg and Diphenhydramine 25mg was taken. The remainder of that day and the following day headache, fatigue, mild dizziness and low grade temp. continued. By Feb.8th, symptom free and well. Rapid onset of symptoms, exacerbation of symptoms and high fever very concerning with this influenza vaccine.
The patient was reportedly in her USOH until she received the first dose of the Pfizer vaccine on 1/4. She woke up the following morning with a terrible headache and photophobia, later in the day developing myalgias and generalized weakness, followed by possible fever (did not take home temp). She describes the headache as a throbbing holocranial ache that is worse if she bends down She states the headache never really went away fully over the ensuing days, and she did begin to notice blurred vision in her right eye; she eventually presented to  Medical Center on 1/9, where she was tested for COVID-19 and found to be negative - her symptoms were attributed to a vaccine reaction and she was sent home. She continued to have a terrible headache and blurred vision, and so returned to Medical Center on 1/12. She then presented to another Hospital she was admitted for frequent falls in the context of elevated blood pressure. Workup there included a head CT, which was unremarkable. She was discharged with home PT.   On the day of presentation, she fell at physical therapy. Now with pain from R knee down. No numbness in the leg. States leg twisted when she fell. No head strike or LOC. States pain with attempted ambulation. This resulted in her presentation to the ED at a Medical Center on 1/27/21.   On evaluation, she endorsed a headache, holocranial, throbbing, 5-6/10 (has been 10/10). Denies frank positional component. Not worse at any certain time of day. +Blurred vision, worse on the R. +photophobia, not phonophobia. Also complains of pulsatile tinnitus happening almost daily, R-sided, worse when bending down. Denies nausea or vomiting. Denies neck pain or stiffness.   Exam was notable for significant peripheral vision loss in R>L eye and bilateral papilledema. She was seen by ophthalmology with documentation of formal visual field testing (reports included). MRV with filling defects in straight, sagittal, and R transverse sinuses; MRI without FLARE changes, reassuring for no obstruction and/or infarct.