chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. Information on the concurrent condition, medical history and pertinent drug allergies of the patient were not reported. On 24-NOV-2015 at time- 11:46, the patient was vaccinated with improperly stored RECOMBIVAX HB lot # L016427 (expiry date, dose #, route, dose units and anatomical location were not specified). Concomitant medication was not reported. No adverse events were reported. The high temperature and low temperature at which the product was stored were 3.0 and 1.9 (units unspecified) respectively. There were no Product Quality Complaint (PQC) involved. This is one of several reports received from same reporter. Additional information has been requested.
Seen in ER. Voice hoarse, throat swelling, difficulty breathing within 5 minutes of vaccine administration. Neb treatment with Racemic Epi; BENADRYL (IV), Solumedrol (IV); VENTOLIN and Albuterol Neb.
The 8th day after shot injection area became very itchy again and hot; Overnight night sweats; Area around injection site is red; A lump it is currently one and 1/2 inches; Itching at injection site/ injection area became very itchy again; Soreness at injection site; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 13:30 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID -19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included hydrochlorothiazide/ triamterene (TRIAMTERENE HCTZ) for an unknown indication from an unknown date and unknown if ongoing. On 03Mar2021, the patient experienced soreness at injection site 3 days then itching at injection site (06Mar2021) for 2 days and then nothing. The 8th day (on 10Mar2021 at 20:00) after the shot, the injection area became very itchy again and hot. The patient also experienced overnight night sweats and the area around injection site was red, hot, itchy and a lump of one and half inches at the time of reporting. The patient also reported that, 9th day was slightly worse than 8th day. The patient hoping this was normal but she thought it was important that people know all side effects. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event soreness at injection site was recovered on 05Mar2021, while that of itching at injection site/ injection area became very itchy again, hot at injection area, overnight night sweats, area around injection site is red and a lump it is currently one and 1/2 inches was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Stomach upset after the 2nd dose; Leg cramps after the 2nd dose; Feels like has to go to bathroom after eats after 2nd dose; Fever after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach upset after the 2nd dose), MUSCLE SPASMS (Leg cramps after the 2nd dose), DIARRHOEA (Feels like has to go to bathroom after eats after 2nd dose) and PYREXIA (Fever after 2nd dose) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014m20a and 032m20a) for COVID-19 vaccination.     No medical history was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (Stomach upset after the 2nd dose), MUSCLE SPASMS (Leg cramps after the 2nd dose), DIARRHOEA (Feels like has to go to bathroom after eats after 2nd dose) and PYREXIA (Fever after 2nd dose). At the time of the report, ABDOMINAL DISCOMFORT (Stomach upset after the 2nd dose), MUSCLE SPASMS (Leg cramps after the 2nd dose), DIARRHOEA (Feels like has to go to bathroom after eats after 2nd dose) and PYREXIA (Fever after 2nd dose) outcome was unknown.            No treatment information was provided. Concomitant product use was not provided by the reporter.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.
On the 2nd day after receiving 1st dose of the vaccination, I developed a small case of hives that developed into blisters on my left foot near my toes.  This issue resolved within a week.    Approximately 2 1/2 weeks after receiving the 1st dose of the vaccination, I began to experience pain and stinging on my right arm and on my head/scalp on the right side.  This developed into a rash within 2 days of the pain, then began to blister behind my ear and on my scalp.  I also started to develop a rash on my back, similar to the issue on my scalp and behind my ear.  The pain and burning was progressing along with the increased presence of blisters,  I went to the Clinic on Friday, April 2, and referred to ER  - and was diagnosed with an outbreak of Shingles.  I was given Valacyclovir HCl to treat the outbreak.
Headache, red bumpy rash spread all over body. Took benadryl to try and help the rash.
pt recv vax 12AUG96 & 21AUG96 pt devel 3 varicella lesions located on the face, groin & back;pt recovered by 23AUG96;
Nerve pain, leg weakness, inability to walk, falls Hospitalization and rehabilitation Lumbar puncture: test of spinal canal fluid MRIs, and EMG test 5-day infusion with IVIG
It felt my feet was burning.  I then began feeling like I had a cold.  I had body aches and sore throat. I also had a headache, SOB, and nose congestive.  Then, I started having pain in my neck.  I had rapid heart beat.  My legs started hurting really bad.  On Jan 2nd, I went to the clinic for a Covid-19 test, positive results. Then on Jan 9th, I did another Covid-19 test, positive result.  These symptoms are still ongoing as of today.
Flu-ish symptoms going on second day, starting eight hours post shot.  Body aches, chills, malaise, slight nausea
The night of the shot, I developed body aches, fever, and chills. These persisted into the following day and were mostly gone by the day after that.
Redness, swollen lump under skin at injection site; swollen lymph node in left armpit
Dizziness, nausea, chills, tired/heavy feeling In legs, odd sensation in right leg with numbness of right toe. Blood pressure and heart rate mildly elevated beginning around 10:40 pm 1/5/21. Spoke with a triage nurse twice late pm 1/5/21 and early am 1/6/21. Advised self monitoring. Unable to sleep more than about 1 hr at a time-woke up sweaty. No temp. Woke up without dizziness/nausea but had dizziness when eating cereal and looked down. Saw general practice physician 1/6/21 after 10 am 1/6/21. Given anti-dizziness med. prescription.  Dizziness/nausea, Tired/heaviness in legs gone when saw physician. Still mild altered sensation in right leg and big toe numbness that comes and goes. Elevated blood pressure at physician. Bloodwork ordered and scheduled for Saturday.
According to the patient, starting several hours after vaccination, the arm became very red, swollen, hot and painful. She iced the area, and took some benadryl, but had trouble sleeping, due to the pain.  Next morning, she noticed the red area became larger. She called us at the pharmacy, and we suggested she continue icing and take tylenol or ibuprofen for the pain, and let us know if it didn't resolve. Second day after  the vaccinations, she came to pharmacy to show us. The red area was now about 5 inches in diameter. We suggested she continue treating the arm, and contact her primary doctor  if it continued to spread or looked infected. She denies any trouble breathing.
Received varicella vaccine L arm on 3/31/08.  Patient brought by mom today 4-2-08 with swelling, redness, bullae, warm to touch on vaccine site.
This spontaneous report concerning a patient of an unknown gender and age was received from a medical assistant. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, lot and expiration date were not provided). There were no concomitant medications reported. On an unknown date, the patient experienced a bad case of poison ivy (dermatitis contact). No product quality complaint was involved. At the time of reporting, the outcome of the event of dermatitis contact was unknown. The causality between ZOSTAVAX and the event of dermatitis contact was not assessed. Additional information has been requested.
Pt has had a sore arm since 10/30/20 (over 6 months). He says he can't even lay down on it
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a consumer (wife) concerned a 59 year old unspecified race and ethnic origin male. 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, and batch number: Unknown and expiry: Unknown) dose was not reported, 1 total, administered on 01-APR-2021 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 immunological vaccine failure. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Negative, Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000183050.; Sender's Comments: V0:20210632841-COVID-19 VACCINE AD26.COV2.S-Suspected Immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive 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
I had no reaction to the initial vaccination.  On February 21 ? 8 days after the vaccination ? I awoke with a bit of swelling, light redness, and a slight itch at the vaccination site.  I understand this is called "COVID arm" and am only reporting it for research purposes.  The swelling has not increased and I have no real pain.  I have no concerns about this reaction.
Pt recv vax on unknown day; on 1/27/99 pt exp erythema & itching at vax site
Left Arm - swelling and redness--rash approximately 5 days after the injection.  Stayed red for about 3--4days and subsiding. Completely gone by 5/8/2021.
My left lymph node is very painful and very uncomfortable to move around. I noticed the symptoms before I went to work around 7 am. I talked to the pharmacist who gave it to me and she looked at the area and told me to take a motrin for the pain and keep an eye on it. Before I left work I talked to the other pharmacist on duty and she thinks I could have slept wrong and pulled a muscle. She said to wait a few days and if it doesn?t get better go to a doctor.
the vaccine that was administer covid-19 moderna booster (NDC 80777-275-05) and it should be toddler
Patient received MMR, DTaP, HIB on Friday, 7/14 at PMD. Saturday had fevers and some malaise but not too bad and treated with OTC  Tylenol and Motrin. Sunday, 7/15 was having worsening fever, lethargy and vomiting and at that point noted to have anemia (H/H - 7.6/25), platelets of 33 at the outside facility however repeat labs here were reassuring H/H 9.5/28 and platelets 197. Patient was monitored for several hours and reassesed in ED and ultimately improved and was discharged to home on 7/16. Returned on 7/17 with ongoing fevers and then wtih altered mental status. Patient had broad work up including CBC, CMP and head CT. CT found - Multiple areas of low attenuation noted in the bilateral frontal lobes, temporal occipital region, bilateral cerebellar hemispheres, right greater than left. These lesions are multiple on both sides of the brain and somewhat symmetric. No abnormal enhancement is seen. No shift of the midline. Ventricles and basal cisterns are patent. Possible tiny areas of intraparenchymal specks of blood in the left periventricular region. I am uncertain if they correspond to artifact. This can be best evaluated with MRI. These areas of stroke- like appearing can be seen in multiple conditions including, but not limited to, encephalitis, ADEM, metabolic disorders (MELAS), vasculitis, etc.   Patient admitted to ICU for work up of stroke. Ultimatley obtained MRI and thought not to be stroke but likely inflammatory in nature. Infectious work up negative. Developed true thrombocytopenia and anemia. Rheumatology, ID, Neuro, Heme all consulted and following patient. Ultimately received IVIG and now clinically improving over the past 48 hours with another night of observation. Labs also improving with ongoing consideration of bone marrow biopsy.   Fevers over the weekend on Saturday. High fevers to 103 on Sunday for which they went to a local ED and were sent to Hospital.
On Wednesday 02/22/2023, at approximately 10:30 AM, an unsheltered 57-year-old male patient was approached and offered COVID-19 vaccination by team. After searching patient?s vaccination record on Registry system, EMT and RN, PHN noted two patient accounts with the same name and date of birth.  The first patient profile was unviewable and despite a work-around, profile still stated "Sharing Date must fall between birth date and today's date". The second profile did not display any COVID-19 vaccinations. EMT and RN, PHN searched for patient?s name and DOB on system, which also displayed no previous vaccinations. EMT and RN, PHN asked patient several times if he received any COVID-19 vaccines in the past and patient denied receiving any previous COVID-19 vaccines.  RN, PHN and EMT asked which COVID-19 vaccine patient wanted to receive and provided vaccine education and information for Pfizer and Moderna COVID-19 vaccines. Patient requested to receive Moderna COVID-19 vaccine as a primary dose.  Patient was educated by, RN, PHN on risks, benefits, common side effects, and when to seek emergency care.  Patient verbalized understanding and consented to receiving Moderna COVID-19 vaccine.  At 11:02 AM, patient received Moderna monovalent COVID-19 vaccine (Lot #: 074B22A) as a primary first dose on (right deltoid), administered by RN, PHN.  Patient denied experiencing any adverse symptoms during post-vaccination observation period.  When RN, PHN began to document this patient?s Moderna monovalent dose into the system, a Pfizer monovalent COVID-19 dose displayed (Lot: FK9896) on 01/26/2022.  At 11:04 AM, RN, PHN completed a medical consultation with on-call physician Dr. regarding previous Pfizer COVID-19 vaccination. Dr. suggested that the patient receive a COVID-19 bivalent booster two months from now.  RN, PHN informed patient of COVID-19 bivalent booster recommendation and observed patient leave area with steady balance and gait.
Start to have hives and mild swelling in face 3 days after vaccination. These symptoms go away after about one week and come back again couple days later. It still happens intermittently and lasts until now.
Burning sensation in palms and feet, sweaty palms and feet, severe headache, extreme fatigue, anxiety, general weakness.
Pt had significant erythema, edema & warmth to upper arm (injection site) systemic symptoms included fever chills, HA, myalgias, fatigue starting the day after injection until today.
rash on chest and underarms; itching; congestion; This is a spontaneous report from a non-contactable pharmacist. A 68-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 1 intramuscular on 02Feb2021 (Batch/Lot Number: EL9265) as DOSE 1, SINGLE (at the age of 68-years-old) for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 05Feb2021, the patient developed rash on chest and underarms 3 days after first dose of COVID-19 vaccine. The patient was already taking hydroxyzine for itching and Zyrtec for congestion before reaction. Her PCP recommended she still get the second shot but take Benadryl and Pepcid 1 hr prior to the vaccine and for every 6 hours after for 5 days. It was not known whether another vaccine in four weeks was taken by patient. Therapeutic measures were taken as a result of events. The patient received treatment for the events with hydroxyzine, Zyrtec, possibly Benadryl. It was unknown whether the patient had COVID prior vaccination and whether the patient got COVID tested post vaccination. The clinical outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Patient fainted and became short of breath. Epinephrine and diphenhydramine administered and patient transferred to the emergency department.
Menactra Red, Swollen, hot to touch, itching rash encompassing a dinner plate size on the right thigh which started the night of vaccine administration. TDAP Red rash encompassing a small dinner size plate with itching which started the night of vaccine administration. Ice packs were used the night of administration.  Visit to office on 7/1/2021 and given PRID to apply to sites.  Was told to return if reaction worsens.
Noticed hives shortly after 1 woke up on 1/9/21. ~10am. Hives were white and all over legs and on back of my arms. Also had temp of 99.3..could be due to hives. Took benedryl and symptoms subsided 1/9/21 in the evening.
Patient reported red, warm skin rash on arm vaccine was administered in. Said rash extended from around the elbow up to around the shoulder area. Rash was limited to that area only. Patient did not report any other adverse effects. Patient said rash appeared approximately 7-10 days after receiving first dose of Moderna.
No additional AE; Administered after labeled expiry date; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 18-JAN-2021, the patient was inadvertently vaccinated with an expired dose of Hepatitis A Vaccine, Inactivated (VAQTA) 25 U/25 ml, 1 dose, lot # S032359 was confirmed to be valid, expiration date 11-JAN-2021, (route and site of administration were not reported) for prophylaxis. There were no known temperature excursions on vaccine. The nurse inquired about need for revaccination. No additional adverse event was reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Information has been received from a physician concerning a 11 year old male who on 02-NOV-2000 was vaccinated with a first dose of MMR II (route, site, dose and lot number not reported). On 22-NOV-2009, the patient experienced mumps (diagnosed on 23-NOV-2009). The patient was afebrile and had parotitis (both sides). On 23-NOV-2009, first blood work was done (<1;10IgM, 6.55 IgG, serum amylase 255). On 30-DEC-2009, the patient was vaccinated with a second dose of MMR II (rHA) (route, site, dose and lot number not reported). The outcome for mumps was not reported. No further information is available.
Hot all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 65 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, 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 immunisation. The following information was reported: FEELING HOT (non-serious), outcome "unknown", described as "Hot all over". Therapeutic measures were taken as a result of feeling hot.  Additional information: Aspirin was taken as treatment of the event hot all over.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
About 15-20 minutes after receiving the vaccination patient complained of numbness in throat and slight swelling. Said he had no difficulty breathing. I gave patient 50mg of diphenhydramine and observed patient for an additional 15 minutes, at the end of this time patient said numbness had resolved and the swelling was gone. I counseled both mom and patient to call 911 if patient were to experience difficulty breathing later in the day or if throat swelling/numbness returned. About 6 hours after vaccination patient complained tingling in legs and feet but no throat numbness or swelling, advised patient to go to urgent care. of Also advised patient to follow up with pcp.
Splenectomy; This spontaneous report was received from a pharmacist concerning a currently 59 years old patient of unknown gender. Information regarding the patient's concomitant therapies, current conditions and medical history was not provided.   On an unknown date in 2020, the patient was vaccinated with one dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (strength, route of administration, lot number and expiration date were not provided) for prophylaxis.  On 25-JUN-2021 (confliction information: also reported as 25-JUL-2021, the patient had a splenectomy performed. At the time of the report, the outcome of the splenectomy was unknown.   Causality assessment was not reported.  Upon internal review, the splenectomy was considered to be medically significant.
Fatigue, fever, body aches started on 4/6 late morning. Fever of 99.6 in evening, aches and fatigue continued through the night to the next morning. I slept a lot. On Wednesday 4/7 I felt better mostly but felt tired at a few points during the day. Thursday I felt back to normal. Friday I felt a little itchy spot on my left arm near injection site, not bad just slightly noticeable.  Otherwise I feel great now on Saturday.
2 CM RED FIRM/ TENDER AREA WITH 2 CENTRAL HEALING VESICLES AT VACCINE SITE
one week after shot patient states he has swollen lymph node in neck the same side as the vaccinaton arm.  Patient has not been seen about the reaction.  The swelling is still present at this time, the time of his second shot.
Vomiting, severe muscle pain, swollen lymph node under right arm, severe headache. On Feb 21st started having severe pain in both legs from the knees down to the ankles. No swelling, but ice and ibuprofen lessened the pain some. Still also have tenderness in right arm from when shot was administered. Wondering if the pain my legs is related to the shot. Have also had small headache since having shot everyday.
Patient said that she had a burning sensation down her back and into her leg and arm on the side that the shot was administered. That sensation went away after 1 to 2 hours.  Her left arm also was twitching during that time period. This morning, 12 hours after vaccination she is nauseated and has a headache.  She has not taken any medication.