chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red face; Rash all over her body; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red face) and RASH (Rash all over her body) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No medical history information was reported.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, the patient experienced ERYTHEMA (Red face) and RASH (Rash all over her body). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, ERYTHEMA (Red face) and RASH (Rash all over her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Patient Demographics was added and Date of birth was added
Headache, shaking/shivers, stomach aches, went to ER on 9/18, had blood work done treated for pneumonia (with Z-pack) and for RBC.
Got intranasal on Fri 11/13/2009. Vomiting @ 8:-8:30pm, chills, sweat, head congestion, running nose, headache x2 days. Groggy and fatigue. Took MOTRIN for HA.
This case was reported by a physician and described the occurrence of injection site induration in a female subject of unspecified age who was vaccinated with BOOSTRIX (GlaxoSmithKline). There were no concurrent medications. On 19 May 2011 the subject received unspecified dose of BOOSTRIX (unknown). On the same day of BOOSTRIX administration, 19 May 2011, the subject experienced a local reaction with symptoms of injection site induration, injection site tenderness and injection site redness. The subject was seen on 02 June 2011 and was still complaining of local reaction. At the time of reporting the outcome of the events was unspecified. The physician considered the events were possibly related to vaccination with BOOSTRIX. Follow-up information received via the physician on 06 July 2011 indicated that the subject was a 77 year old, menopausal female. BOOSTRIX was administered at 0.5 ml in the left deltoid on 19 May 2011. On the same day, 19 May 2011, following vaccination with BOOSTRIX, the subject experienced a local reaction with injection site induration, injection site tenderness and injection site redness. The events resolved by 02 June 2011. In the reporter's opinion, the events were possibly related to treatment with BOOSTRIX. The subject had a history of hypertension and  high cholesterol. This case was reported by the same physician as linked cases A0932824A, A0932826A and A0932827A.
One week after injection my arm was really sore and then i noticed it was red with bumps on my skin and it felt warm to the touch.  Plus have big lump where injection was given
Fever, 100.8 for day and a half, chills, and bad headache. Three days later notice ache in left armpit. As days progress left breast was hurting and swelling on side of breast. Had a slight green color to skin in armpit and down side of chest. Also arm was sore from armpit to middle of arm  on inside of arm. It has been two weeks now and my breast is still slightly swollen on left side near armpit and I am concerned. This is my first shot and what will happen if I get the second.  The breast still bothers me. If I had to do it again I thing I might not of got the vaccine.
Woke up around 1:30 am next morning with chills and fever of 100.5.  Took 2 Tylenol, drank some warm tea, and water.  Fever decreased to 99.9 within an hour after taking Tylenol.  The chills also went away.  It was around 7 am before fever was gone.  Felt very achey and tired rest of the day.  Took Tylenol  every 6 hours  for 3 more times.   Felt dehydrated.,  pushed lots of fluid including  pedialyte. Woke up next day feeling fine but still a little tired.  still pushing fluids
malaise; fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative.  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunization; Bnt162b2 (2nd dose), for COVID-19 immunization. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "malaise"; FATIGUE (non-serious), outcome "unknown", described as "fatigue".  Follow-up attempts are completed. No further information is expected.
On 2/22/01, pt's mom called and informed us that he had a red blotchy rash 2-3" around the injection site. Mom gave him Benadryl. That evening he had a prickly rash on both legs and on his back which came around to his sides; he also had large red circles on both cheeks and a fever of 99.1F.
severe pain in her right arm, where she had the injection; she is having pain in her arm which has moved to her spine; her back area is really hurting; This is a spontaneous report received from contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 18 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03May2021 12:30 (Lot number: EW0173) at the age of 18 years as dose 1, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: Tb shot (Manufacturer: unknown, Lot Number: unknown, injection on left arm, AE(s) following prior vaccinations was None), administration date: 13Apr2021, reaction(s): "no adverse effect".  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 04May2021, outcome "not recovered", described as "severe pain in her right arm, where she had the injection"; SPINAL PAIN (non-serious) with onset 04May2021, outcome "not recovered", described as "she is having pain in her arm which has moved to her spine"; BACK PAIN (non-serious) with onset May2021, outcome "not recovered", described as "her back area is really hurting".  Additional information: The reporter was reporting on behalf of her daughter. The patient complain of severe pain in her right arm, where she had the injection, and now the pain has moved to the back of her spine. She had the vaccine 3 weeks ago and experienced back pain as well, not as severe, and it comes and goes. The patient was first tuberculin test was from a blood draw by her doctor for college. The severe pain in right arm moving into spine was reported as worsened. The patient did not visit Emergency Room or Physician Office. did not receive any vaccinations prior COVID vaccination within 4 weeks. Patient did not had Medical History (including any illness at time of vaccination) and Relevant Tests.  No follow-up attempts are possible. No further information is expected.
Swelling and tenderness at the site of injection for 3 days after the immunization.
Pt had sort of seizure like activity for approximately 15 seconds, was pale and weak.  Vomited about 10 minutes after shot.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Mild, Systemic: Hyperventilation-Mild, Systemic: Seizure-Mild, Systemic: Tachycardia-Medium, Additional Details: Patient has h/o vasovagal syncope which was not mentioned until after vaccine was administered
Tingling Numbness Hot Flushed skin a burning sensation in my arms legs and stomach I also had a headache
Pain developed at injection site at 24 hrs after injection. At 48 hrs, pt developed an area of erythema around the proximal arm.
the nurse giving the injection, said that most of the vaccine came out between the syringe and the needle. The patient received half than less of the dose. After calling our Clinical Coordinator, we were instructed to re-administer the vaccine.
Pt had T-DAP on 8-8-14 - She stated reaction started on 8-15-14. Area to (L) deltoid is red-hard-painful - warmth started on 8-5-14.
Rash developed about a week after shot dose two. Rash on both thighs above knees. Rash on abdomen. Rash under arms. Rash on when's. Rash under armpit . no rash at injection site.
Initial report received on 09/Aug/2006 from another manufacturer, report number 1-72861229, (initial report was form the patient who is also a physician). An adult patient (gender and age not specified) had self-administered an injection of Decavac, lot number not reported, on an unspecified date. Route and site of administration were not reported. At an unspecified amount of time post-vaccination, the patient developed an injection site infection. Recovery status was not reported. Additional medically relevant information not provided.
Pt received Engerix vax @ 10:20  & @ 10:45 became dizzy, pale, c/o "not feeling good" sat down & rested 45 min & went home but still continued to feel woozy this persisted until bedtime. 18 hrs later she had no complaints. Recovered 30May90
Fever.  Achy body.  Sore throat.  Very sore arm at injection site
EVERYTHING TASTE LIKE METAL; This spontaneous report received from a patient concerned a female of unspecified age. 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) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be required for this case. No concomitant medications were reported. On an unspecified date, the subject experienced everything taste like metal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of everything taste like metal was not reported. This report was non-serious.
The patient called this morning and stated that she woke up with hives all over.  She had gotten a flu shot for the first time and wasn't sure if it was related.  She stated she did not changed soaps, detergents, or had any usual food.
This spontaneous report as received from a pharmacist via field representative on 10-NOV-2014 refers to a 67 years old female patient. On 31-OCT-2014 the patient was vaccinated with a dose of ZOSTAVAX (strength, dose, lot# and route were unknown). The pharmacist reported that a patient was diagnosed with shingles after receiving ZOSTAVAX. The pharmacist reported that the patient had abdominal pain which "felt like she pulled a muscle", and then the patient noticed the rash. The patient was diagnosed with shingles by her physician on an unknown date of 2014. The patient was in a lot of pain. The patient was treated with oral antiviral therapy, antiviral ointment and pain meds. On 10-NOV-2014 saw unspecified physician for seeking medical attention. The outcome of event was reported as not recovered/not resolved. Additional information has been requested.
This spontaneous report as received from a Registered nurse refers to unspecified patients of unknown age and gender. The concurrent conditions, drug reactions/allergies and medical history of the patients were not reported. On 01-FEB-2017, the patients were vaccinated with a dose of improperly stored GARDASIL 9 with lot number M030380 and expiration date of 01-FEB-2019 (strength, dose, route of administration and anatomical location were unknown) for prophylaxis, which was stored at 1 Celsius degree for 24 hours. There was no previous temperature excursion. The temperature excursions were not detected by a data logger. No concomitant therapies nor adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Shortness of breath, cough onset Sunday April 4th.  DATE OF SERVICE: 04.06.2021   CT ANGIOGRAPHY, CHEST (CPT=71275); PULMONARY EMBOLUS PROTOCOL; 3-D RECONSTRUCTION  CLINICAL INDICATION: SOB (shortness of breath)  COMPARISON STUDY: 10/9/2020  TECHNIQUE:  Axial images of the chest were performed during dynamic contrast enhancement for the  optimization of the opacification of the pulmonary arteries, following IV administration of 80 mL of  Isovue 370. Three-dimensional reformation into the coronal plane was performed.  Automated exposure control and ALARA manual techniques for patient specific dose reduction were  followed while maintaining the necessary diagnostic image quality.  ADVERSE REACTION: None  FINDINGS:  PULMONARY ARTERIES: There is a large filling defect within the right interlobar artery, extending  into the lobar, segmental, and subsegmental branches of the right lower lobe. There is expansion of  the right interlobar artery by this thrombus. Small filling defect is noted within the distal left  main pulmonary artery, with some extension to the left upper lobe and left lower lobe lobar  segments.  HEART AND VASCULATURE: The heart is normal size. No pericardial effusion. There is no evidence of  right heart strain.  MEDIASTINUM AND HILA: There is no mediastinal or hilar lymphadenopathy.  LUNGS AND AIRWAYS:  Heterogeneous densities are seen in the right lower lobe, new since the prior  exam. Scarring is noted in the superior segment of the right lower lobe as well as in the anterior  left lower lobe..  PLEURA: Small right pleural effusion.  CHEST WALL, LOWER NECK, AND AXILLA: Grossly unremarkable.  UPPER ABDOMEN: Grossly unremarkable.  OSSEOUS STRUCTURES: Degenerative changes are seen within the visualized spine.  IMPRESSION  1.  Bilateral PE, with extensive thrombus on the right and minimal thrombus on the left as detailed  above.  2.  Small right pleural effusion and heterogeneous right lower lobe consolidation, likely reflecting  pulmonary infarction.
Possible adm. of only vial 1 was given to pt. not discovered until all 5 doses were adm. from the box. Unable to determine what pt. did not get unmixed dose
Mother of the minor, by phone call refers that minor presents redness and hot to the touch in the area of vaccination the next day. 10/12/2022.
Injection site has become a large, red, circular (2'' D) welt.  It is no longer hot or sore, but it is not dissipating.  It began about a week after I received the injection.  Initially, I had zero reaction whatsoever.
couldnt lift up head or sit up, when able to stand was very weak and shaky, dizzy, headaches
c/o foreign sensation in throat immediately after COVID-19 vaccine administered. no signs of airway, breathing or circulation complications. Diphenhydramine 25mg  given with resolution of symptom & pt discharged home.
Systemic: severe migraine-Severe, Systemic: Headache-Severe, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: Severe migraine day after coadministration of vaccines. trip to hospital. no sign of stroke per visual images.
Breakthrough case after vaccination. Tested positive for COVID 1/11/2022. C/O cough, fever, muscle aches, and headache, onset 01/11/2022
Information has been received from a consumer referring to her 23 year old female daughter without any drug reactions/allergies. The patient's concurrent condition included blood pressure abnormal. The patient had pregnancy within the past two years (captured in case 1509USA012758). In 2009 (reported as "about 6 years ago"), the patient was vaccinated with a complete three doses series of GARDASIL (dose, frequency, route and lot number not provided). The reporter was unsure if it was a GARDASIL or GARDASIL 9 vaccination. Concomitant therapies included unspecified blood pressure medications and "DEPOCERA". The patient was diagnosed with an unspecified HPV type on 09-SEP2015 after a routine pap smear. The patient sought medical attention via clinic visit but she had not received treatment yet. She planned to go to a gynecologist for follow-up. The outcome of papilloma viral infection was reported as not recovered/not resolved at the time of reporting. This is one of two reports concerning the same patient. Additional information has been requested.
Pt devel red splotches on leg & leg became swollen pt was unable to walk on leg; pt taken to clinic & told was allergic to DT;
body aches, chills, fatigue and malaise, rapid heart beat while sleeping (caught by apple watch 123 beats per minute, sleep rate is usually low 50s to 60), very painful and heavier than usual period that i felt really bad during
Patient received the Pfizer Covid Vaccine on 12/31/2020 while she was on day 4 of antibiotics.  On 1/6/2021, patient started to have a rash and difficulty breathing.  Patient went to ER and was prescribed a different antibiotic.  Patient has been on both antibiotics before and has never had a reaction to either.  This may be a duplicate report.  I did not receive an email confirmation so resubmitting.
Rash on abdomen, groin, arms, and back of legs that then turned to dark brown spots that remin visible one year later.; Rash on abdomen, groin, arms, and back of legs that then turned to dark brown spots that remin visible one year later.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 18Aug2021 at 18:00 as dose 2, single (Lot number: FC3181) at the age of 42 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Open angle glaucoma" (unspecified if ongoing), notes: Other medical history: Open angle glaucoma; "COVID-19", start date: 28Jan2021, stop date: 28Jan2021, notes: Positive. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE NUMBER: 1, Batch/Lot No: EW0179, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 28Jul2021, when the patient was 42-year-old, for COVID-19 Immunization. The following information was reported: RASH (disability), SKIN HYPERPIGMENTATION (disability) all with onset 21Aug2021, outcome "recovered with sequelae" and all described as "Rash on abdomen, groin, arms, and back of legs that then turned to dark brown spots that remin visible one year later.". The events "rash on abdomen, groin, arms, and back of legs that then turned to dark brown spots that remin visible one year later." required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (28Jan2021) Positive, notes: Nasal Swab. Therapeutic measures were taken as a result of rash, skin hyperpigmentation includes Triamcinolone. Clinical course: Patient had no other vaccine in four weeks. No known allergies.
Initial information received on 14-May-2018 regarding an unsolicited valid non-serious case received from a health care professional. This case involves a patient (Age and gender was not reported) who was vaccinated with dose of PENTACEL (batch number, expiry date, route and site of administration were not reported) on an unspecified date. It was actual medication error due to inappropriate reconstitution technique. As the sterile diluent was used to mix the ACTHIB and the components were administered separately. 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.
Extremely sore arm with raised rash which is somewhat hard and inflamed, aches, fever, and fatigue.   Symptoms started at about 10 pm on April 6th, day of vaccine until morning of April 8th.  Fever started first and continued until morning of April 8th, took last temp at 5 am.  Arm was very sore and could not lay on it to sleep, aches developed during the course of the night.  Fatigue was all day April 7th slept all day.  I took Tylenol prior to symptoms starting since I had worse reaction with first shot and more Tylenol throughout the day.  I didn't notice the rash on my arm until the morning of April 8th.
A couple hour after vaccine, I experience hyperglycemia. I passed out and was unresponsive, Ambulance service was called to provide service. They gave me dextrose. The estimate date is 09/2/2021
10 mins p/vax pt exp weakness, dizziness, sl-mod dyspnea & throat tightness & VS were low & weak; BP 112/50, 16, 52; also pale w/circumoral pallor & cold; some irregular pulse occurred; shivering;  slept 12 hrs;
Skin pale, cold & clammy, lethargic, eyes rolling, t102 R extremities w/s l tremor;
Patient became ash in color, demonstrated decrease level of consciousness. Medical immediately attended to pt. Assess vital. Monitor pt 45 mins after event. Prior to d/c-pt verbalized felt much better, ambulated without syncope.
This serious spontaneous case, was received from other health professional (registered nurse) on 01-Jun-2017 and concerns students in an academic campus, who received flu vaccine. This case deals with fifth of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns 14-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 19-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch number 185888, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore, no internal root cause could be confirmed. Outcome of influenza A virus infection and vaccination failure was not reported. The reporter did not provide the seriousness assessment. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (QAIR number 1022277) received from quality assurance department on 29-Jul-2017: QA investigation result was updated. Narrative amended accordingly. Non-significant case correction received on 10-Aug-2017: Narrative and case comment were corrected.