chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a company representative via Physician's nurse refers to a 2 months old male patient. Pertinent medical history was none. On an unspecified date, the patient was vaccinated with dose 1 of ROTATEQ 2 milliliter (ml) orally. Lot number and the dosing details were not reported. Concomitantly the patient received PEDIARIX, PEDVAXHIB and PREVNAR. On an unknown date, the patient experienced explosive, bloody diarrhea and general malaise without fever after receiving the first dose of ROTATEQ. The patient sought medical attention and the patient was taken to the emergency room and checked for hydration levels and did not need to be treated for dehydration. The outcome of explosive, bloody diarrhea and general malaise was reported as recovered/resolved. Additional information has been requested.
TEMPERATURE EXCURSION OCCURRED DUE TO THE PLACEMENT OF HAND WARMERS IN THE INSULATED BAG USED TO TRANSPORT VACCINE. ALL 81 PERSONS RECEIVING VACCINE IN LANES 5 AND 6 AT THE DOH ON 02/15/2021 BETWEEN 14:00 and 16:45 WERE NOTIFIED THEY  RECEIVED VACCINE THAT WAS OUTSIDE OF THE APPROPRIATE TEMPERATURE RANGE AND WERE RECOMMENDED TO BE REVACCINATED.
flu is light; Initial information received on 24-Dec-2022  regarding an unsolicited valid social media non-serious case received from a consumer/non- healthcare professional (hcp).  This case involves an unknown age and unknown gender patient whose flu is light after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for flu vaccination (Influenza immunisation).  On an unknown date, the patient developed a non-serious event of flu is light (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (flu is light).  At time of reporting, the outcome was Unknown for the event flu is light.
Patient called said was in pain and had swelling in the arm. Told patient it sounds like a type of reaction to the vaccination and to seek medical treatment at the er.
Allergic reaction only to covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in May2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 12 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer (dose 2, lot number unknown), administration date: Jan2022, when the patient was 11 years old, for COVID-19 immunization; Pfizer (dose 1, lot number unknown), administration date: Dec2021, when the patient was 11 years old, for COVID-19 immunization. The following information was reported: ALLERGY TO VACCINE (non-serious), outcome "unknown", described as "Allergic reaction only to covid vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309430 same reporter/patient, different dose number/event;
Arm soreness for 12/25 and 12/26-resolved 12/27 Pain in left axillary area on 1/1/2021 as well as arm soreness returned. Axillary pain resolved on 1/2/2020 and arm soreness resolved on 1/3/2020. Arm soreness for 12/25 and 12/26-resolved 12/27 Pain in left axillary area on 1/1/2021 as well as arm soreness returned. Axillary pain resolved on 1/2/2020 and arm soreness resolved on 1/3/2020.
Positive Covid-19 test three weeks prior to admission, and repeat positive test one week prior to admission, presented to ED for evaluation of dyspnea, productive cough, and occasional hemoptysis.  Outpatient he was treated with prednisone, Zithromax and amoxicillin, but failed to improve.  His condition failed to improved while inpatient, DNR wishes were honored.
It was probably a lowkey feeling. I had a low-grade fever and started developing a cough. It was a lot of fatigue and tiredness. It felt pretty bad after the first full day. I called my doctor and got the PAXLOVID prescription. I took it, not sure if it helped. It seemed to help. I feel fine now.
Syncope labored breathing, sweating, pallor, Patient complaints of all muscles in body tightening and cramping.
Heart palpitations; headache; dizziness; This is a spontaneous report from a contactable Consumer (patient herself). A 27-years-old non- pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, lot number: EN6208, expiry date: unknown) via unspecified route of administration, administered in right arm on 14Mar2021 15:15 (age at vaccination: 27-years) as DOSE 1, SINGLE for Covid-19 immunization. Facility type vaccine other was state organization. Medical history of patient included migraines and penicillin allergy from an unspecified date and unknown if ongoing. Concomitant medications were not reported. No other vaccine was administered in four weeks. The patient had surgery / general anesthesia on 09Mar2021 (in two weeks of vaccination). The patient experienced heart palpitations, headache, dizziness on 15Mar2021 12:00. Prior to and since vaccination the patient was not tested positive for covid. Treatment regimen was not given as a result of the adverse events. The outcome of the events was not recovered.   No follow-up attempts are possible.  No further information is expected.
pt recv vax 24JAN97 & in 1997 pt devel zoster w/fairly typical vesicles on an erythematous base on back,  neck & arm opposite the inj site;
I had a sore arm for a few days after receiving the vaccine. I was diagnosed with heart murmur, and I had an aortic valve replacement surgery on 02/01/2023. I am taking cardiac rehab since my surgery.
Patient complains of hives at injection site (HPV9). They are still occurring daily, 1 month after the injection. He also c/o numbness of his face, it gets worse when the hives appear.
pt received 1st pfizer covid shot at 3:47 pm. she told me she had a history of anaphylaxis to oral benadryl and i counseled her that she should wait 30 minutes for observation after the immunization. around 4 pm she notified my technician the outside of her throat was starting to feel hot and itchy. i took her into the room and sat her down in private. I gave her an ice pack to put on her throat and was observing her when the itching started on her abdomen. I advised her she was having an anaphylactic event and she denied me calling ambulance or using epipen. Around 4:05 pm she asked for some cream so we gave her some hydrocortisone cream OTC that she applied to itchy area on chest and throat and she said she was feeling better. Around 4:15 she told me the itching was starting inside her mouth and allowed me to call 911 and administer one dose of epinephrine 0.3 mg in her left thigh. The fire department came around 4:20 and started talking to her and taking vitals. blood pressure was 146/90 and heart rate was 100 even with the epinephrine causing her to shake. They advised she wait for emt's that arrived around 4:30 pm and they conviced her to go in the ambulence to the hospital even though she was feeling fine since there was a chance the epi would wear off and she would need more help.
Rash noted the following morning. ~2mm lesions- macular? very slightly raised. Trunk. Couple on palms.
Client complains of arm being tender where immunization was given if pressure is applied.  Indention below right deltoid.  Client's family looked at arm and refered her to a physician.
PER MOM, CHILD HAD FEVER, FELT HOT TO TOUCH,BODY ACHES,WEAKNESS,CHILLS.
when received the vaccine he got nausea that was mild, it continued and got worse on the 11th and 12th, the 13th he threw up from being sick, headache, fatigue, chills were all experienced through this time with muscle pain.
p/vax pt devel wheal rash on flexor surface of arm/elbow & anterior thigh 3hrs p/ vax; persisted x 3d a/ pt went to sick call; dx: urticaria w/ unk etiology
Redness to legs and arms and feet, pt was breathing fast. Face was swollen and red, white around mouth, and crying a lot. 1:15 pm pulse ox 95% RA. 1:20 pm Epi (R) thigh 0.125mg. 1:25 pm Methylprednisolone 20mg IM (L) thigh. 1:25 pm BENADRYL 12.5mg po. 1:30 pm Erythema decreased. Respirations unlabored. Vitals: pulse 93 POX 97% RA. Pt. crying. Redness to legs and feet decreasing at 1:25 pm. Pt breathing strongly. Rash to back seems to be going away. 99% 139 heart rate. Pt's (R) arm seems more irritated than (L) arm. Sleeping. 1:40 pm Pt now snoring and breathing very strong. Pt's face still swollen, red and ears as well. 95% 122 heart rate. (R) arm is now getting better almost all the red and swollen is off. Pt breathing through his mouth due to stuffy nose. 1:47 pm Pt not snoring anymore, pt seems much calmer, breathing better. Face, ears, feet still red. Nipples and around nipples are popping out/as per someone seems okay. 1:50 pm Rash to body getting smaller. Face still swollen and red, ears as well. 97% 121. 2:10 Pt still asleep, ears still red and swollen. 100% 122 heart rate.
This spontaneous report was received from a consumer and refers to herself, an approximately 60 year old female patient with immunodeficiency, allergies to sulfonamide and alfuzosin hydrochloride and a history of lymphoma treated with unspecified chemotherapy. On 13-FEB-2017, the patient was vaccinated with ZOSTAVAX, (dose, lot number and expiration date were not reported) subcutaneously for prophylaxis. Concomitant therapies included CLARITIN, ZYRTEC and an unspecified nasal spray. In approximately MAR-2017, (reported as "about 6 to 8 weeks ago"), the patient developed "small bumps that look like blisters" periodically on her "arms, back of legs and ankles". Also the patient stated that "the bumps would go away eventually but would take a very long time to heal" and "usually when one bump would heal another bump would appear somewhere else on [her] body". The patient also described the "small bumps" as "looking like mosquito bites but when [she] scratched them the top of skin comes right off". It was reported that the patient previously had "lymphoma" and had finished her treatments of chemotherapy "sometime last year". The patient then stated that although her lymphoma had "cleared up" (unspecified date) her primary physician considered her to be "immunocompromised". On 17-MAY-2017, the patent reported that she met with a physician about her experience with the small bumps on her body and was going to see another physician on 19-MAY-2017 for this same event. At the time of this report, no treatment was given for the event. The patient underwent "standard blood test" (results not provided). The outcome of small bumps that looked like blisters was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
seizure; This is a spontaneous report received from a contactable pharmacist (patient) via medical information team. Follow-up (06Apr2021) was received from same reporter and processed together with initial information.  A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8729; Expiration Date: 20Jul2021), via an unspecified route of administration on 06Apr2021 as SINGLE DOSE for covid-19 immunization. Other suspect medications included: saline [sodium chloride], via an unspecified route of administration from an unspecified date (Lot Number: 6023228), at unspecified dose for an unspecified indication. The patient medical history and concomitant medications were not reported. The patient reported that after administering the Covid 19 vaccine on 06Apr2021, within about 20 minutes there were 4 patients with reactions. One patient had a seizure and 3 patients passed out. These patients had just received the Covid 19 vaccine and were still being watched within the 15-minute post vaccination time. All 4 patients received the Covid 19 vaccine from the same lot number but not from the same vial. Seriousness of event was medically significant. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information in the case report and strong temporal relationship, A possible causal relationship between event Seizure and suspect drug  bnt162b2  cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Information has been received from a registered nurse concerning 2 children who were vaccinated with varicella virus vaccine live. Subsequently, the patients recently developed chicken pox. Unspecified medical attention was sought. It was reported that other patients had similar experiences following exposure to varicella virus vaccine live. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients with 18 years old. No pertinent medical history or concurrent conditions were reported. The reporter stated that, on an unknown date, the "state" (referring to the state Health Department) was giving unspecified doses of GARDASIL 9, (dose, frequency, lot # and expiration dates were not provided), to pediatric boys through age 18 years old. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Fever, bad fatigue and bumpy rash on arm area on 15-16; a week later painful swollen hives and left and right side on my ears and the side of my face and neck last 2 weeks on April 2, 2021. Saw doctor on March 24, 2021 asked to Benadryl and steroid and went back March 26 and March 30, 2021- telehealth and prescribe steroids.
Felt like her head was going to explode. She felt hot, woke up with sore throat and post-neck pain.
Presents for SOB x2 days, fever, cough, N/v; COVID+ x7days PTA. Admit for COVID pneumonia.  Tx: remdesivir, O2, dexamethasone. DC home on O2
Patient was given the Moderna vaccine for the first 2 series of shots but the Pfizer for the 3rd.
mom reports pt began shaking around 1130AM & cont until called well child staff & was instructed to go to hosp immed; mom gave APAP; pt felt hot-fainted; pt had febrile sz; also had BOM;
Intense pain and muscle weakness in left arm (injection site).  Cannot lift left arm to shoulder height.  Pain is continuous.  Joint stiffness and weakness as well.
Patient is a 60 y.o. male who received the Janssen COVID 19 Vaccine lot #1805020 on 3/12/2021.  The patient experienced the following reaction(s) during the immediate of observation:  9:05am Patient c/o dizziness during observation period. Patient evaluated in treatment area. Reports PMH of HTN, depression, and anxiety.   Patient was treated/managed as follows:   9:05am VS BP 150/92, HR 56, RR 18, 96% on room air. Patient states symptoms are same.  9:15am VS BP 146/86, HR 60, RR 20, O2 sat 97% on room air. Patient reports feeling better.  Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance.
expired dose of PENTACEL being administered with no adverse event; Initial information received on 03-Mar-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 4 months old female patient who had been administered with expired dose of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13); and Rotavirus vaccine live reassort oral 5V (Rotateq).  On 01-Mar-2023, the patient being administered with an expired dose 2 of 0.5 ml once of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine Suspension for injection with no adverse event (expired product administered) (lot: UJ651AA, expiry date: 25-Feb-2023) via intramuscular route in the left thigh with standard strength for immunization.  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.
Red raised rash on the left arm of injection site measuring 3x3 inches  The rash is warm to touch, itching, with mild pain noted.
Lips are slightly itchy, patient is feeling tingling in hands. After 20 minutes tingling in extremities.
At 1431, pt received the first dose of the Moderna COVID-19 vaccine. Hx of anaphylactic reactions to penicillin as a child. At 1445, pt started complaining of tongue swelling, which proceeded to increase in severity. At 1449, Epi-Pen administered (0.3 mg) in R deltoid. At 1450, 50 mg diphenhydramine IM administered in L deltoid, followed by an additional dose at 1452 in R deltoid. 911 was called between 1445 - 1450. Pt was moved to another exam room where she could lay down because she was hypotensive, lightheaded, and pale. O2 sats remained between 95-98%, BP 81/53-190/100, P 94-136, RR 16-24 throughout. Tongue swelling improved slightly after receiving Epi-Pen. EMS arrived and were able to start an IV before transporting her to the local hospital at 1502.
Information has been received as part of a class action suit concerning a pregnant female who was vaccinated with hepatitis B immune globulin. Subsequently, the patient's daughter experienced toxic neurological effects of mercury poisoning, considered serious. The onset date was unknown. Relevant history and concomitant medications were not provided. The outcome of the event was unknown. Toxic neurological effects of mercury poisoning was considered to be an other important medical event (OMIC). No further information is available. This report was received from the manufacturer's legal department on 12/14/04.
Confusion, diaphoresis, tunnel vision, hypoxemia Narrative:  Admitted to hospital from emergency room after presenting with altered mental status. Found to be hypoxic, given D50 and CT of head. CT negative, felt better with oxygen and was admitted to floor on telemetry. No cardiac irregularity on monitor during hospitalization. MRI of brain had no evidence of acute CVA subdural or acute abnormality to explain altered mental status that improved without anything more than hydration. CBC and chemistry panels were normal grossly, sugars were not a problem, blood pressure well controlled. Discharged to prior living circumstances. Was not given 2nd COVID injection.
This case was reported by a pharmacist and described the occurrence of bumps around injection site in a 71-year-old female subject who was vaccinated with BOOSTRIX (GlaxoSmithKline). On 24 July 2012 the subject received 1st dose of BOOSTRIX (.5 ml, unknown, left arm). On an unspecified date in 2012, less than one month after vaccination with BOOSTRIX, the subject experienced bumps around injection site. At the time of reporting the event was unresolved. At the time of the report no other information was provided.
About a week after my booster I broke out in hives all over my body that lasted about a week. I am still getting rashes/dermographia daily all over my body over a month later.
This spontaneous report as received from a healthcare professional refers to a patient of unknown age and unknown gender. The patient's pertinent medical history was not reported. On 01-MAR-2016 the patient was vaccinated with GARDASIL 9 (lot number: L014415, expiry date: 25-JUL-207), dose 3. The patient was previously vaccinated with GARDASIL dose 1 (lot number: K004546, expiry: 11-AUG-2016) on 15-AUG-2014 and Dose 2 (lot number: K004546, expiry: 11-AUG-2016) on 31-OCT-201. The patient received first 2 doses of GARDASIL and completed series with third dose as GARDASIL 9. No adverse effects were reported. No product quality complaint was reported. Additional information has been requested.
stomach did not feel good; no appetite; not sleeping well; nauseous; did not feel well; felt tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 83-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID- 19 VACCINE, solution for injection), administration date 18Jan2021 (Lot number: EL3247, Expiration Date: 20May2021) at the age of 83 years as dose 1, single and administration date 08Feb2021 (Lot number: EN9581, Expiration Date: 31May2021) as dose 2, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: NAUSEA (non-serious) with onset 15Mar2021, outcome "not recovered", described as "nauseous"; MALAISE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "did not feel well"; FATIGUE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "felt tired"; GASTRIC DISORDER (non-serious), outcome "unknown", described as "stomach did not feel good"; DECREASED APPETITE (non-serious), outcome "unknown", described as "no appetite"; INSOMNIA (non-serious), outcome "unknown", described as "not sleeping well". Therapeutic measures were taken as a result of gastric disorder.  Additional information: The events did not require a visit to emergency room and physician office. The patient had no prior vaccinations within 4 weeks.   No follow-up attempts are possible. No further information is expected.
Very sore arm at injection site and the joint above.  The above continued for 8 to nine weeks.
Dizziness, abdominal pains, chills when sleeping, paleness in skin, sore throat, ear infection. 2 days aster the show the Sx's showed up.
Information has been received from a physician concerning three female patients who on unspecified dates were vaccinated with first doses of Gardasil (lot # unknown) injection and fainted. Medical attention was sought. On unspecified dates at the time of reporting all three patient's recovered. No additional information was provided. Additional information has been requested.
On January 18, 2023 I tested positive for Covid-19. I experienced nasal congestion; low grade temperature; slight cough.
Development of tachycardia. anxiousness around time of first shot (5.9.2021, second shot
DIAGNOSIS of CELLULITIS ON 9-22-20 AT URGENT CARE. REDNESS, SWELLING + PAIN THROUGHOUT ARM. FEVER. PATIENT PRESCRIBED ORAL Doxycycline + INSTRUCTED TO RETURN TO URGENT CARE ON 9/24/20 FOR FOLLOW UP
10Feb96 pt recv 1 dose vax. 18Feb98 pt devel varicella-like rash.A few on stomach & hairline.
Had fever 99.7 for 1 day, bad body aches for 3 days. Extreme pain at the injection site and was unable to use left arm for 3 days.