chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a health professional concerning a 14 month old female patient with no pertinent medical history or drug reactions/allergies, who on 03-MAR-2010 was vaccinated with RECOMBIVAX HB (lot number 665366/0890Y). Concomitant therapy included VARIVAX (WAES 1003USA00607). It was reported that on 03-MAR-2010, after receiving RECOMBIVAX HB the patient developed injection site reactions. The arm which got RECOMBIVAX HB developed tiny blisters at injection site. At the time of the report the patient was recovering. The patient sought unspecified medical attention. No laboratory diagnostics studies were performed. Follow up information has been received from the Registered Nurse who reported that the welts were resolved before the patient left the office. Follow up information has been received from the Registered Nurse who reported that on 03-MAR-2010 at 15:30, the baby with no illness at the time of vaccination, was vaccinated intramuscularly in the left arm with a dose of RECOMBIVAX HB (lot number 665366/0890Y). Concomitantly the patient was vaccinated subcutaneously in the right arm with a dose of VARIVAX (WAES 665193/1049Y). It was reported that the same day at 15:30 the patient developed an area of erythema at both injection sites with a small hive. Ice was applied. The reaction lasted approximately 15 minutes then resolved. The patient was referred to the allergist. No further information is available.
Post-Menopausal Bleeding lasting 10 days after initial vaccine.  Post-Menopausal bleeding since 11/4/2021 after 2nd.
Vomiting, high temperature of 103. Loose stools. Went to doctors office on 11/10/16 and was told stomach virus. High temp continued off and on until 11/12/2016. 11/12/16 rash broke out on child's trunk, from groin all the way to neck, was not on ANY extremities, covered his back as well. Never continued to vomit. Called pediatric office again, they said it could be a viral roseola, if it came back to bring him in. 11/17/2016 PM, another rash broke out, same areas, however different appearance. Almost looked like chicken pox but had no "head" on the red bumps all over him. Called pediatric office again, took him in 11/18/16 at 8:30 AM, was told it was a reaction to "something" but maybe foods. He has not had ANY new foods, nor have we changed anything else around the house. Rash has continued to date. Pediatric office advised Claritin and oral steroids on 11/18/16, said if it was not better to return to them Monday 11/21/16 and they would do bloodwork. Was advised this morning all bloodwork is normal. Rash still remains.
Generalized joint/body ache, weakness, fever (flu-like symptoms). The following day, patient reported pain (10/10) in left shoulder and left leg, brought down to 7/10 after administration of ketorolac 30 mg I.V. once.
This spontaneous report as received from a physician refers to herself, a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, route and lot# not reported) and the needle separated from the syringe. The physician received less than the prescribed dose of ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Pt has a history of vasovagal responses after medical procedures - which he did not admit to until after he had been vaccinated. He has a very brief episode of syncope at the station where he received his vaccine. He was assisted via wheelchair to the EMS station and was monitored for 30 minutes. His father was with him because of his history and both agree that he will be given his second dose while laying on a cot.
10 days later I was riding my bicycle I developed low back and left leg pain, I gad MRI scan, I had herniated disk at L4-L4, I will see a surgeon tomorrow.
Sudden appearance of a bright red inflamed rash on the backs of my hands, seemingly from washing a small plate. For the first days I could not figure it out. It did not respond to the usual OTC skin preparation I use successfully for eczema, etc. I kept it soothed with a good hand lotion. I gave it a week to disappear on its own. When it did not I contacted my MD on 03/18/21. She believed it to be erythema multiforme, prescribed fluocinonide 0.05%, and told me to discontinue any other topical applications. Unfortunately my pharmacy did not have it until 03/20/21. That gave it enough time to worsen considerably. The ointment has been effective, but on 03/31/21 I am not done with an angry rash as yet.
Started with mild hives on hands and torso and progressed to hives all over body.  Swelling inside mouth.  Had prednisone in the house.  Used prednisone.  Hives under control.
Wed: approx 3-4 hrs post-vaccination, arm became hot/swollen, extending into the lymph nodes under arm, into breast. Applied ice. Thurs: next day experienced more of the above, with mild fever. Fever spiked to 102 degrees that night, unrelieved by ADVIL. Fri: next day (called physician's office). Began taking ADVIL alternating with TYLENOL. Fever improved, then went back up to 101 degrees. Sat: arm still red, hot, swollen, sore area traveling distally. Mild fever. Sun/Mon (today): arm STILL red, hot, swollen, sore.  **I would not have gotten this vaccine had I known!!**
Within an hour of injection, the injection site started swelling, red and warm to the touch.  Within 1 day, I experienced a headache, shivering (especially with cold hands), and muscle aches along the back of my legs.  The swelling, warmth, and redness have increased to an area almost the size of my palm.  Cold packs, ibuprofen, and acetaminophen have not alleviated any symptoms, which are ongoing at this time.
Had delayed itching about 30 hours after first dose but brief and minor.  Had slight minor itching within 15 minutes of second dose but brief and minor, taking benadryl before injection and twice after.  Then 3 days later (injection on Fri 5:00 pm) reaction Monday 3:00 pm) noticed hives on both hands and some small spots on arm and itching. Over next 2 hours noticed injection site had large irregular rash-y area. Was in another county getting first aid and cpr training ironically, even going over how to use an epi-pen. Could not take benadryl as had to drive 45 min home. Started driving home and began feeling very bad with chest tightness, more itching, decided better to go to ER half-way to home as I live out in the county.  At triage bp was 180/111 and had tachycardia, I think they said 145 bpm. They did EKG labs etc.  Dr. diagnosed allergic reaction and tachycardia.  Administered oral and IV meds and IV fluids and was discharged and home by 8:15 pm.  feel fine the next day, but taking steroid and antihistamine prescription level medications to control.  Meds given at hospital listed: zyrtec tablet 10 mg Pepcid 20 mg Benadryl 50 mg Solu-Medrol 125 mg NS -0.9 1000ml Lopressor 5 mg  Home medications Hydroxyzine HCL 25 mg 1 tab every 6 hrs prn Prednisone 20 mg 1 tablet 2x daily 5 days
headache; feeling nauseous; whole body felt achy; chills; This is a spontaneous report from a contactable other hcp (patient). A non-pregnant 26-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL9265, Expiration date were not reported), via an unspecified route of administration, administered in the left arm on 04Feb2021 (at the age of 26-years-old), as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EL3249, Expiration date were not reported), via an unspecified route of administration, administered in the left arm on 14Jan2021 17:45 (at the age of 26-years-old), as dose 1, single for COVID-19 immunisation. Concomitant medication included unspecified birth control and venlafaxine, both taken for an unspecified indication, start and stop date were not reported. Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that patient experienced headache, the morning after the vaccine on 05Feb2021. About an hour later, on 05Feb2021, patient started feeling nauseous but that subsided relatively quickly. About three hours after that, on 05Feb2021, patient's whole body felt achy and she had the chills. She did not present with a fever at this time. No treatment was received as a result of the events. The outcome of feeling nauseous was recovered on 05Feb2021 while the rest of the events recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 27Oct2021 12:00 (Lot number: FF2590) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; SPIRONOLACTONE; TRELEGY; OMEPRAZOLE. The following information was reported: COVID-19 (medically significant) with onset 06Nov2021, outcome "unknown", described as "COVID-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (06Nov2021) positive, notes: Rapid antigen, nasal swab. Additional information: patient had no known allergies. Patient did not have COVID-19 prior to vaccination. It was unknown if patient received other vaccine in four weeks.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200047534 Same reporter/patient/drug, different dose/events
My entire vaccinated arm was very sore and painful when I used the arm muscle to pick heavy things and carrying them.  Also the muscle felt weak.  The injection site was not red or swollen but if I touched it I could feel the pain of the injection.  The injection site pain lasted for at least 4 months.  A month after the vaccination I noticed the pain started to get better on my upper arm.  Slowly, over 6-7 months, the pain got better from the shoulder down to the mid forearm.  It has now been 6-7 months and the pain is only in the mid fore arm when I flex the muscle to pick things up.  I reported it to employee health and was told to take Motrin.
13ARP92 approx 2 hrs p/recvd 1st dose of Engerix-B devel sx; no tx given; sx have improved;
I have a swollen eye with pus. Eye and ear pain, seen an ophthalmologist. Vaccine flared up my Lupus.
mom stated p/vax 23AUG94 5PM pt became very agitated & restless w/unconsolable shrill loud cry lasting approx until 9PM; mom informed MD of occurence @ next visit scheduled that same week; request of record sent; mom stated MD advised DT
HPI Patient is a 72 y.o. female with a history of metastatic bladder cancer with currently in chemotherapy who presents to the ED via EMS for evaluation of abdominal pain. She stated that she had a round of chemo yesterday. She started to have abdominal pain which has continued and worsened.  Reports that she had abdominal pain for a long time but it seems to have been worse over the past couple days when they had thought that it was due to her being constipated. Patient also has been very weak and unable to stand on her own. At baseline she is able to get around with a walker. EMS was called and gave her 1.5 mg of IV dilaudid and 250 ml of saline while en route.   She describes it as diffuse abdominal pain but mostly in the lower part.  She also admits to dysuria but not frequency.  She also gave history to cough and constipation that turned into loose stools after she received enema today.  Per her grandson, she has been a bit more confused over the past week.  Denies sick contacts and COVID exposure.   In ED, febrile with T 102.6, hypoxic in mid 80s,  tachycardic and slightly tachypneic.  Saturation 96%.  Blood pressure within normal.  Labs revealed no leukocytosis, normal lactate hemoglobin 8.2, platelet 103, magnesium 1.3, calcium 7.6 otherwise electrolytes unremarkable, albumin 2.0.  VBG with pH of 7.4, PCO2 of 35, HCO3 of 22, PO2 34.  UA reveals no esterase, presence of bacteria, WBCs.  CXR no acute disease but CAP revealed bilateral pulmonary emboli and extensive bilateral common femoral and profunda femoris DVT extending into the superficial femoral veins bilaterally, adrenal metastasis that has progressed, perihepatic ascites, subtle lesions in the liver (cannot exclude metastasis).    HOSPITAL COURSE:   72 y.o., female, w a PMH of Bladder Ca with metastatic disease on chemo, who was admitted on 1/21/2022, with generalized weakness found to have bilateral pulmonary embolic, extensive bilateral DVT, COVID pneumonia with acute hypoxic respiratory failure and Sepsis, GPC bacteremia/UTI. After discussion with family/ patient, palliative care, heme/onc and hospital medicine decision was made to focus on comfort, patient died on 1/27.
PATIENT SLUMPED OVER THE CHAIR AFTER THE VACCINE. DIDN'T PASS OUT.
2:17 pm, Suddenly client felt faint, Layed her in exam room table gave, water & crackers, 2L 02 via adult face mask sat 100%. vitals; 139/82  HR 98. 2:30 felt, cold & clammy, shakey and tingling body & nausea vitals 125/70 HR 95 O2 sat 100% . By 3:00 previous symptoms subside , new symptoms dry mouth, headache 7/10 and nausea vitals 145/85 HR 105, taken of 2L 02. Called 911, emergency transport to AV emergency room. Patient choose to be driven to AVH emergency room by daughter who was at her mothers bedside during observation.
My period came a week and a half early. Usually, I menstruate for 3-5 days on a predictable schedule because I am on the pill. I have now had my period for nearly a month. The bleeding is not as heavy as when it started but is still enough to fill half a menstrual cup a day.  I have not had an irregular period in at least five years.
Redness/swelling of right upper extremity 3-4 hours after vaccine (PNEUMOVAX).
Post PROQUAD vaccine patient with thigh swelling approx 1-2 hours after injection and continued to swell for approx 36 hours. Seen in office 48 hours after injection. Swelling/induration approx 14 cm with warmth and itching. Given BENADRYL every 6 hrs for 72 hours and cold compresses. Swelling resolved at 48 hrs, itching after 72 hours.
Sore arm, swollen lymph node in armpit, fatigue, generalized muscle ache,  feeling feverish
Pt rec'd Td with no apparent problems directly after injection. Walked to front desk to check out. Within 5 min fainted while standing. Fell to floor & hit back of head on rug-covered carpet. Revived within a few minutes. Rested in lobby about 45 min. c/o of blurred periph. vision. Recommended MD visit - mom will take. 6/30 mom reports headache x 1 day with neck soreness - better today.
This spontaneous report as received from a medical assistant refers to a 9 month old female patient. On 16-SEP-2013, the patient was vaccinated with a pediatric dose of RECOMBIVAX HB, 5 mcg, lot # 668060/1519Z, expiration date 29-MAR-2013 (route was not provided). On 16-SEP-2013, a dose of RECOMBIVAX HB with expiration date of 29-MAR-2013 was administered. No adverse effect was reported. At the time of the report, the patient's status was unknown. Additional information has been requested.
Mom states patient was lethargic for 1 1/2 days after receiving HPV#2. Also lethargic for 5 hours after 1st dose on 8/12/14. He required no treatment and we didn't hear about the reaction until mom called recently to explain why she was cancelling the appointment for HPV #3.
Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness). At the time of the report, DIZZINESS (Dizziness) outcome was unknown.            No concomitant medications were reported. No treatment was reported.
cellulitis; redness; swelling; rash; pain; This is a spontaneous report from a contactable nurse via a Pfizer sales representative.  An 18-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on an unspecified date at single dose for immunization. Patient had MS (multiple sclerosis). The patient had no concomitant medications. No other vaccines were administered at time of meningococcal group b rlp2086 vaccination. After first dose the patient experienced redness, swelling, rash and pain, possible cellulitis after vaccination. Patient received vaccine on Friday. The patient took diphenhydramine hydrochloride (BENADRYL) over weekend and patient was better by the following Monday. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: A possible causal association between administration of TRUMENBA and the onset of possible cellulitis cannot be excluded assuming a plausible temporal association.  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.
Dizziness immediately after getting; Headache immediately after getting/ experienced headache behind her eyes; Rash up arm and across chest; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  This is 2nd of 4th case.  A female patient received bnt162b2 (BNT162B2) (Lot number: FC3181, Expiration Date: 31Oct2021) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness immediately after getting"; HEADACHE (non-serious), outcome "unknown", described as "Headache immediately after getting/ experienced headache behind her eyes"; RASH (non-serious), outcome "unknown", described as "Rash up arm and across chest".  Additional information: Received call from pharmacist regarding the Pfizer COVID vaccine.  She is a pharmacist at (Pharmacy name) and has noticed a few side effects from 4 patients in one week that are all the same and are coming from the same Lot FC3181.  She is wondering if Pfizer would recommend she quarantine the batch.  She has given over 200 out of that batch.  She did not have any patient information to provide today and requested to be transferred to have her question answered.  She completed VAERS reports for the patients. She stated she will go online and use the QR code to complete Pfizer reports as well. She is just trying to see if she should keep giving.    No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101069070 Same reporter/drug, different patient/similar AE
diarrhea x 2 wks; vomitted 1 1/2 p/vax; anorexia x 2 wks p/vax; abdominal pain when defecating, irritable;
Severe headache Elevated blood pressure 191/106 - 188/101 Continued 12/16 thru 12/17  Three days later appears to be returning to normal  Still tightness in chest Sunday 12/19 Blood pressure :131/78
My first and second one was done at another center and I felt muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 64 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 64 years as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "moderate asthma with no 'general lungs' " (unspecified if ongoing), notes: she is suffering from asthma. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "My first and second one was done at another center and I felt muscle pain".  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Angioedema of the right lower lip. Prednisone and Benadryl prescribed, Lost to follow-up.
Temp, extreme fussiness from 27+ hours post immunization (03/07/08) until 03/09/08 8:30 pm.
Information has been received from a physician concerning a female who was vaccinated with ZOSTAVAX (Merck) 0.65ml. The patient had herpes and got the vaccine and patient was doing better now. Lot number was not provided. No additional information was provided. Additional information has been requested.
This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 01-JUN-2017, the patient inadvertently received an expired dose of GARDASIL (strength, dose, frequency were not provided) lot # M014929 with expiration date of 27-MAY-2017, intramuscularly for prophylaxis. No adverse adverse effects were reported. There was no product quality complaint (PQC) involved. No further information was provided. Additional information has been requested.
COVID-19 mRNA LNP-S, bivalent PF 6mos-5yrs (Moderna), 10 mcg/0.2 mL (wrong dose given- under dosed)
INJECTION SITE PAIN; 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced injection site pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injection site pain was not reported. This report was non-serious. This case, involving the same patient is linked.
Increased hand and arm tremors, Elevated FSBG (>500) Nausea, decreased mobility, increased confusion, sore throat with Inability to eat or drink