chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial misuse report received from a healthcare professional on 14 Mar 2014. A patient whose demographic details, medical history and concomitant medications were not reported received a dose of Tetanus Toxoid on an unspecified date. (Route, dose, site and batch number not reported). It was reported that on an unspecified date patient received expired vaccine. No adverse event was reported. Documents held by sender: none.
BURNING, REDNESS AT SITE OF VACCINATION (LEFT SHOULDER), FATIGUE, MUSCLE SORENESS, JOINT PAIN, ALL OVER ACHINESS, NAUSEA, UNABLE TO EAT, DIZZINESS, HEADACHE, LOW GRADE FEVER (101).
Fever. Patient seen for well child physical on 4/28/15 and received routine 2 mos vaccinations. Pt developed fever 100.6 and fussiness that eve. Went to ER - WBC elevated. ROCEPHIN given IV. BC and UC done. F/U in office on 4/29/15 - temp 98.4 TA in office. ROCEPHIN given in office on 4/29/15. BC neg. UC neg.
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 01Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 08Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm and on 16Apr2022 at 17:00 as dose 4 (booster), single (Lot number: FK9893) at the age of 75 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Lobectomy for lung cancer" (unspecified if ongoing); "peripheral artery deseasr" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN; CYMBALTA; DULOXETINE; COZAAR. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Rash developed at injection site, noticed it this morning around 8:00 am. By this afternoon it began to itch.
erythema, warmth, tenderness & swelling @ site of inj 7.5cm;
Patient went to an emergency room for pain and fever and was diagnosed with pancreatitis, something she has never had an issue with before the vaccine.
Chills; Muscle pain; Fatigue; Flu like symptoms; Arm swollen size of a baseball and radiating heat at site.; Arm swollen size of a baseball and radiating heat at site.; This is a spontaneous report from a Non-contactable consumer. A adult female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunisation. the patient's medical history included covid-19 (If covid prior vaccination: Yes).  She was vaccinated on a Monday. Tuesday, the patient experienced chills, muscle pain, fatigue, flu like symptoms. Friday she experienced arm swollen size of a baseball and radiating heat at site.  This Adverse event resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if the patient received any treatment. The outcome of the events was recovered.  No follow-up attempts are possible. Information about batch/Lot number can not be obtained.
Myalgia & Fever Narrative: Night of first vaccine dose patient had body aches, low grade fever, and chills. Symptoms resolved by morning. Pain at injection site.  Other Relevant History:
Pt experienced erythematous papular rash on cheeks, neck, back and shoulders.
Vaccinee did not seroconvert following a 3 dose series; Vaccinee rec'd a 3rd Engerix-B vax (deltoid) on 24APR90; 8AUG90 "Hepatitis-BS Antibody Titer- negative".
PATIENT ALREADY RECEIVED THE COMPLETE SERIES OF SHINGRIX, FIRST DOSE ON 11/06/2019 AND SECOND DOSE ON 01/07/2020.  INADVERTENTLY GIVEN THIRD DOSE.  PATIENT ALSO RECEIVED TDAP (BOOSTRIX) ON SAME DAY BUT IN LEFT ARM.  STATES HAD "FLU LIKE" SYMPTOMS FOR A FEW DAYS AFTER RECEIVING BOTH SHOTS.   REALIZED ON 07/19/2020 OF PREVIOUS DOSES AND CONTACTED PATIENT.  SHE STATES THAT SHE IS FINE.
Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.  Reporter also stated that the vaccines were stored in freezer and they took out one to two vials and placed in fridge each day as needed.
Approximately 3 days after receiving vaccination, I broke out in a bad rash all over my torso. I was seen at a medical facility where I was prescribed Prednisone and hydroxyzine. After finishing the medicine days later, my rash had spread to my legs, lower back, chest, neck and face. I went to health clinic and mentioned that I had received the vaccination. They decided to treat me with the same exact prescriptions that didn?t help me before. My rash is continuing to spread.
about 5 mins p/inject pt was nausea; pale; mom said began to jerk & fainted was unconscious for a few seconds; pt remained sale & clammy for about 10 mins then seen to be OK;
L-ARM RED SWOLLEN 4 X 2 1/2 INCHES , SLIGHT PAIN
evening after tdap fever,chills,headache,dizziness 1 week later rash appears chest and back still symptomatic after 18 days
Reported by mother,who is an RN:  Temp 103axillary w/ chills/fever despite ibuprofen; could not hold head up; refused all food and drink; unable to hold popsicle to mouth; very lethargic. Never had this reaction to a vaccine before.
Arm was extremely sore for 24-48 hours.  Aching from shoulder to below elbow is still present now over two weeks later - worse if I sleep on it.   On Mar 3 both arms went completely limp and then discomfort/pain in upper back/neck area.  Also became slightly nauseous and light headed.  On Mar7 the exact symptoms happened again.  I went to emergency room.  Was also sent to a Cardiologist.  So far nothing extreme has shown up.  Mar 14 I had similar pain/discomfort in upper back/neck, but no limp arms.  I'm advised to see a Neurologist, but am worried I won't get there before my next shot on Mar 18.
The patient developed a lesion the first day post vax. The patient developed several more on ensuing days. The most severe lesions were on his toes and were vesicular in nature with oozing of serous fluid. The patient was seen by his primary care physician on 07/30/2001.
Patient has been diagnosed with achalasia. Her symptoms began in May 2008 with severe chest pain. That became more frequent, along with difficulty swallowing. She is scheduled for surgery.
lot of stomach distress; diarrhea; not feeling good; feeling off and on; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 27Jan2021 (Lot number: EL9262) at the age of 77 years as dose 1, single and administration date 22Feb2021 (Lot number: EN6NO) as dose 2, single both for COVID-19 immunisation. Relevant medical history included: "Nerve pain" (unspecified if ongoing); "Thyroid" (unspecified if ongoing); "Herpes" (unspecified if ongoing); "keep the arteries open" (unspecified if ongoing); "for strengthening bones" (unspecified if ongoing). Concomitant medications included: ZOVIRAX taken for herpes virus infection; GABAPENTIN; LEVOTHYROXINE; CRESTOR taken for arterial disorder; FOSAMAX taken for bone disorder. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "lot of stomach distress"; DIARRHOEA (non-serious) with onset 2021, outcome "not recovered", described as "diarrhea"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "not feeling good"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "feeling off and on ". Therapeutic measures were not taken as a result of abdominal discomfort, diarrhoea, malaise, feeling abnormal.  Additional information: The patient stated that her weight has been between 169 or 170 pounds.  No follow-up attempts are possible. No further information is expected.
I had to test for a flight and came out positive twice.; I had to test for a flight and came out positive twice.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48-year-old male patient received BNT162b2 (BNT162B2), on 04Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 25Mar2021 as dose 2, single (Lot number: EN4207), in left arm and on 23Aug2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 06Jan2022 at 18:00 as dose 4 (booster), single (Lot number: 012H21B), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Congenital Heart Disorder - treated" (unspecified if ongoing), notes: Other medical history: Congenital Heart Disorder - treated. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had to test for a flight and came out positive twice.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) negative, notes: It happened about 5-6 days after I had been negative; (unspecified date) positive, notes: I had to test for a flight and came out positive twice; (21Apr2022) negative, notes: I was negative a day after the last dose; (02May2022) negative, notes: I'm negative again today.
Diarrhea- still present  Insomnia - still present  Headache- comes and goes  Fatigue- 4 days Nausea- 6 days  Swollen Lymph nodes- 2 weeks I have noticed that my right eye is now smaller than my left. I feel like I have a hard time opening it.
12/6/2021 - present (4 days) inpatient admission HCF -  Hospital HISTORY OF PRESENT ILLNESS: Pt is a 89 y.o. male with past medical history of chronic diastolic HFpEF, Afib, restrictive lung disease and recent hospitalization for L1-L2 compression fracture and multiple rib fractures after ground level fall. Patient resides at (PRIVACY) where he recently tested positive for COVID-19 on 12/3. Patient presented to the ED with chief complaint of worsening hypoxia.   Patient was reported to have oxygen saturations in the 80's. He wears 2L oxygen at baseline and reports having a new cough and intermittent SOB. He thinks his symptoms started 1 week ago but is unsure and tested positive on 12/3 for COVID. He is vaccinated with Pfizer although has not received his booster yet. He reportably had monoclonal abx infusion on 12/4. Patient does not recall the infusion and states he received 4 shots for COVID as treatment. He denies having any fever, chills, abdominal pain, vomiting or diarrhea. While in the ED, patient was noted to be in a-fib RVR thus, received cardizem 5mg IV and subsequently became hypotensive.    Upon arrival to the ED, patient was afebrile, tachycardic HR 132bpm, otherwise hemodynamically stable on 4L oxygen. Labs were notable for Na 132, alk phos 145, bilirubin 1.2, wbc 3.29, hgb 9.9, plt 52. CXR showed bilateral pleural effusions slightly decreased in size compared to 11/20/21. No new or worsening opacity. No findings suspicious for overt heart failure. Patient received cardizem 5mg IV subsequently resulting in hypotension. His blood pressure improved with 2L IVF and home midodrine.    Patient will be admitted to HCF for further treatment and evaluation. ASSESSMENT / PLAN:   Iatrogenic hypotension, improving - secondary to IV cardizem - s/p 2L IVF and midodrine - check LA - will hold home lasix and aldactone for now and consider resuming tomorrow - continue BB and midodrine - monitor bp   A-fib RVR- resolved - noted to be recurrent per previous hospitalization - continue BB - tele - keep Mg>2, K>4   COVID-19 infection - vaccinated, did not receive his booster - COVID + 12/3, symptom onset roughly 1 week ago per pt - reported to have had monoclonal abx infusion on 12/4, attempted to call facility to confirm but unable to reach staff - prone positioning daily, tele, continuous pulse ox - trend daily crp, d-dimer - consider monoclonal abx infusion pending discussion with facility    Acute on chronic thrombocytopenia - suspect r/t COVID-19 - monitor cbc   Right arm laceration - wound nurse consult   Chronic diastolic HFpEF - not in acute exacerbation - 9/15/21 ECHO- EF 50-55%, grade 3 diastolic dysfunction, mod AR, mod to severe MR, mod-severe TR - holding lasix and aldactone d/t hypotension, resume when able - continue BB - daily wts, I&O's   Chronic hypoxic respiratory failure Restrictive lung disease Bilateral pleural effusions, stable - stable, baseline 2L oxygen   Deconditioning - lives at facility, own decision maker - PT/OT   DVT prophylaxis: lovenox subq Code status: DNR/DNI Diet: general
14 days post vax pt devel raised,erythema & vesicular lesions w/assoc numbness of lateral upper lt arm;
Received 2nd dose of shingrix 4/7/23 (no issue with first does 1/24/23)  pt reports having fever, chills, rash on admin arm (left)  and across abdomen. after couple days she felt better rash cleared, but her left arm tremors now when she's trying to grip things. other reported conditions include chronic back pain-nerve root disorder.
The patient was monitored for 30 minutes after administration and had no issues; 47 years old male patient received a dose of GARDASIL 9; This spontaneous report was received from a registered nurse referring to a 47 years old male patient. The patient had not received any vaccines four weeks prior. No illness at time of vaccination was reported. No significant past medical history was reported. It was unknown if patient had concomitant medications.  On 14-SEP-2021, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (1 dose, lot# 1637651, expiration date 09-JUN-2022; strength and route of administration were not reported) in left deltoid for prophylaxis (product administered to patient of inappropriate age). The patient had never received any other doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). No other vaccines were administered on this date. The patient was monitored for 30 minutes after administration and had no issues. The patient was told to call if he had any adverse reaction and patient had not called. No product quality complaints was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Pt got a rash (no blisters) on wide area at sigh of injection, 4wks today and rash still there. 2 inches wide 4 inches long, upper left arm.   Pt got flu shot at pharmacy same day as Zoster vacc.
Patient had a 5 cm red injection site reaction which has lasted for 7 days--it is improving.
After receiving the vaccine experienced some tingling in the hand (felt due to increased typing). Later the tingling progressed up the right arm and began feeling ?super? short of breath, feeling she couldn?t breathe. Checked oximeter: HR 172 and O2 sat fine (98-99%). Took a cold bath to bring down HR, HR did improve 122. Symptoms continued to 2- 3am as afraid if should fall asleep. Next morning felt ?usual? side effects of vaccine- fever, aches, and tiredness. Five days later began to have new onset headaches, episodes (~ 3-4) of chest pain and feeling extremely tired (sleepy). Appointment with Cardiologist: EKG- fine, with persistent tachycardia (not sure if historical or new) initiated atenolol (B-blocker). Placed on heart monitor for two weeks, and scheduled follow-up (results pending). Lab findings include elevated CRP- advised to schedule ECHO to check for pericarditis.  ~ 1 and ½ weeks ago had a dizzy/ fainting spell in the shower and plans to discuss with physician during office visit next week.
pt heard a gurgling in lungs;CXR showed a spot;31OCT96 pt recv vax;a few wk later pt stated felt like a flu-like achiness all over body;consulted another MD who referred to neuro;neuro dx condition as chronic inflam demyelinating neuropathy
Fever, sore throat, congestion, cough, blurry vision, sputum production; LE weakness; HA, nausea, lightheaded, dizzy, tingling in feet. Went to ED for MRI-negative; treated HA w/ ibuprofen-resolved; will flu with PCP.
Pt noted an oval shaped, bright red rash on Saturday morning.  As of Monday morning it was resolving.  Denied pain at site or itching.
PT presents to IMMS clinic on 03SEP15 complaining of a hematoma to the left deltoid at the injection site. PT hematoma is the size of a baseball with no pain or drainage with appearance of healing bruising. PT has no hx of bruising due to vaccinations and denies any other symptoms at this time. PT states hematoma is "getting better" since vaccine was administered on 26AUG2015. PT instructed to return to IMMS clinic if it gets worse or any other symptoms occur.
Muscle tightness on her neck; Felt numbness at the injection site; Sores in her head that felt like it had fluid under them; Joint and Arm Pain; Joint and Arm Pain; Swelling, like it affected her brain; She had these sores under her hair, under her skin; Like bruises all over her head; They felt like they were full of fluid so she had to squeeze them; Swelling, like it affected her brain, sores felt like full of fluid and bruises under her hair all over her head was reported as worsened; Slight headache; Chills; Fever; This is a spontaneous report from a contactable consumer (patient). A 64-years-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Right on 01Apr2021 14:30 (Batch/Lot number was not reported) (at the age of 64-years-old) as SINGLE for covid-19 immunization. It was reported that vaccine was not administered at (privacy) facility. Historical vaccine included received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration, administered in Arm Right on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Patient denied for any medications, medical conditions, labs, testing, or treatments relevant to her symptoms. The patient denied for prior vaccinations within 4 weeks. Patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced muscle tightness on her neck, felt numbness at the injection site. On an unspecified date in Apr2021, patient developed sores in her head that felt like it had fluid under them, had chills, fever, joint and arm pain (stated that the pain in her arm has improved), swelling, like it affected her brain, she had these sores under her hair, under her skin, like bruises all over her head, they felt like they were full of fluid so she had to squeeze them and felt it has gotten worsened and stated that now it is just on one side of her head and the other side is back to normal and slight headache. Patient wants to know if there have been any reports of the same reaction with the vaccine. On 05Apr2021, the outcome of chills, fever and slight headache was recovered whereas, sores in her head that felt like it had fluid under them, swelling, like it affected her brain, she had these sores under her hair, under her skin, joint pain and like bruises all over her head was not recovered, arm pain was recovering and for remaining of the events it was unknown.  No follow-up attempts are needed, information about lot/Batch number cannot be obtained.
Warm, red, 2 in diameter area around injection site reported in evening 4/18/05. No pain.
My daughter received the first dose of the Gardasil vaccine and experienced a fainting and short black out episode right after. She returned to ok after approximately 10 minutes but it was very scary and we are watching her for any longer term effects.
patient complaining of a headache in the back of the head with dizziness and nausea. she reported having a headache next day of the vaccine then it disappeared and reappeared again a week later. (patient not sure if same headache.  Blood pressure is normal though
headache, chills, muscle aches, fever, upset stomach, pain in arm where vaccine administered.
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (159558). A male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), on Apr 13, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown, date of administration: unspecified), for immunization. The patient had a headache/dull headache, with outcome of unknown. Additional information: He called to ask if he can take Advil. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Pt's mother called at 4:30pm on 1/3/18, had received these 3 vaccinations at her visit about 3 hours prior. Pt was experiencing 7/10 abdominal pain, had 1 episode of emesis and denied nausea after that first episode. Pt began her period that day but had never experienced abdominal pain like this with previous periods.
Day 6 after Injection: Hives/rash on arms, legs, hands, feet, torso. Itchy and raised.  Treated with 1 Benedryl around 1.5 hrs after rash first appeared. Also used some cortisone cream on the worst areas. Symptoms mostly relieved although some rash still present. Took 2nd Benedryl before bed (10 pm). Day 7 after injection: Hives returned at 4am slightly worse than when it first appeared. Took 1 Benedryl and after 2 hrs the rash started to go down and itchiness greatly reduced. 1 Benedryl around 11am. By evening only a few bumps remained. Residual itchiness lingers. No more Benedryl taken. I have never had a rash or hives like this.  There have been no changes to detergents, soaps, diet.
Itching Hives off and on to current date. Occasional swelling of lips and slight swelling of tongue
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On multiple unspecified dates, the patients were vaccinated with improperly stored doses of ROTATEQ, orally, which had a lot # of M031802 and a lot # reported as "M007301", with expirations dates of 09-NOV-2017 and 19-NOV-2017 respectively. Nevertheless, no adverse effects and product quality complaint were reported. Additional information has been requested.
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE ACUTE LACUNAR STROKE, UNSPECIFIED TYPE AND ARTERY ANAPHYLAXIS, SEQUELA
After receiving Gardasil vaccine pt became dizzy and nauseated. Symptoms subsided after about 10 mins.