chrisvoncsefalvay/vaers-outcomes huggingface dataset:
A report was received from a health care professional on 12/12/03 concerning an unknown number of children of unspecified sex and less than 4 years of age who inadvertently received Fluvirin on an unknown date. On an unknown date, an unspecified number of vaccinees inadvertently received Fluvirin. At the time of the event no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Update 2/23/04: Follow up information received from a health care professional indicated that 31 children aged between 7 months and 3.5 years inadvertently received 0.25ml or 0.50ml Fluvirin between 12/10/03 and 12/12/03. No adverse events were reported. No follow up pending.
Developed swollen burning itching of left ear around 3rd week of November. Developed trouble breathing, inhaling, caugh early January 2022. Saw dermatologist 12/14, saw primary doctor 12/22. Saw ENT 1/4/22. Saw primary doctor 1/10. Saw ENT 1/14. Saw ENT 2/8
Pt arrived at clinic on 6/12/14 and was diagnosed with shingles in one dermatome from the back of her neck down her right arm. She reports intense pain.
Developed Bell's Palsy 3-4 weeks after taking ZOSTAVAX (shingles vaccine). November 20, 2015 had ZOSTAVAX. Left arm very sore and red for two weeks. Dec. 15, 2015 headache and right eye burning. Went to ophthalmologist who said the eye lid doesn't close when you blink. He put lubricating gel in the eye and patched it over night. As the day progressed so did symptoms. Nothing I ate tasted right all day which developed into numbness on right side of my mouth, liquids drooled out, I bit my lip when I chewed and couldn't smile right. December 16, 2015 went back to ophthalmologist who confirmed I had Bell's Palsy. At 1100 I went to neurologist who also confirmed I had Bell's Palsy. He order me drop dose pack and acyclovir. Literature says Bell's often preceded by a virus. I am not diabetic.
4 cm localized erythema and inflammation at injection site, plus induration left thigh. Date time of adverse event are unknown.
1. Injection site pain, tenderness, on February 2-4  2. Fever (never exceeding 101.3), chills, muscle and joint pain, fatigue, headache, cough  3. Productive cough with greenish colored sputum first occurred on February 4 reported to personal pulmonary physician; oral antibiotic prescribed
425 pm, MD gave HPV9. Left room 5 mins later, patient in room alone on exam table. Staff heard fall, patient found on floor hit head had passed out. Juice & crackers given, patient recovered > 20 mins.
patient reported chills and fever 3 days post vaccination, patient had ureteral stents placed earlier in the day before experiencing fever/chills, evaluated and admitted to the hospital until 4/7
This spontaneous report was received from a registered nurse concerning unspecified multiple patients of unknown age. Concurrent conditions and pertinent medical history were not reported. On an unknown date the patients were vaccinated with improperly stored doses of ROTATEQ oral, (lot numbers L008059 (expiration date 18-DEC-2016) and L013193 (expiration date 20-JAN-2017) (dose not provided). Concomitant therapies were not reported. No adverse effects were reported. There was no product quality complaint (PQC) involved. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 08Mar2021 as dose 1, single (Lot number: EN6199), on 29Mar2021 as dose 2, single (Lot number: ER8732), on 02Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 30Mar2022 as dose 4 (booster), single (Lot number: FK9896) at the age of 60 years for covid-19 immunisation. The patient's relevant medical history included: "Hypertension under treatment/control" (unspecified if ongoing); "Hyperlipedemia under treatment/control" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE; WILD ALASKAN FISH OIL PEAK EPA; COQ10 [UBIDECARENONE]; D3; ASPIRIN [ACETYLSALICYLIC ACID]; GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE;GLUCOSAMINE]. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: COVID 19 Treatment; (26Jul2022) Negative, notes: I tested negative by quick antigen test 3 days after Paxlovid regimen; (28Jul2022) Positive, notes: five days after Paxlovid regimen I tested definite positive with Abbott BinaxNow and Acon FlowFlex quick antigen tests; (30Jul2022) Positive, notes: Am still positive by FlowFlex 7 days after Paxlovid regimen. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: Patient received anti-viral drug Paxlovid (Lot number: 607762) from 19Jul2022 to 23Jul2022 for treatment of COVID-19. Patient stated that I tested negative by quick antigen test 3 days after Paxlovid regimen, with gradual reduction in test line to negative, five days after Paxlovid regimen I tested definite positive with Abbott BinaxNow and Acon FlowFlex quick antigen tests. Am still positive by FlowFlex 7 days after Paxlovid regimen (mild congestion, cough, sneezing). Patient did not have any known allergies.
Information has been received from a nurse referring to a 49 years old patient of unknown gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, frequency and lot# were not reported) (Inappropriate schedule of vaccine administered). No adverse effect was reported. Additional information has been requested.
Initial & secondary dose caused lost mobility in arms. Third dose diagnosed with rheumatoid arthritis. 1/5/06 Review of 4-page medical record dated June 2004 indicates diagnosis of probable rheumatoid arthritis warranting aggressive therapy. Meds at that time were prednisone, Vioxx, and Ortho-tricyclen. Autoimmune disease - current diagnosis rhumotoid athritis.
pt broke out w/ chicken pox rash on 11/20/99 @  40 on face;rt leg 3 on buttocks;mom states fluid filled, itchy called on 11/22/99;
Itchy redness on arm, chest, stomach and legs; Extreme tiredness; Itchy redness on arms, chest, stomach, and legs; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 24Mar2021 at 12:30 (at the age of 66-years-old), as a single dose for COVID-19 immunization. The patient did not have any relevant medical history. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had any no known allergies to medications, food or other products. On 29Mar2021 at 06:00, the patient experienced itchy redness on arm, chest, stomach and legs also accompanied by extreme tiredness. On 30Mar2021, the adverse reaction intensified and continued till 31Mar2021 and on same day, the patient visited dermatologist and prescriptions was given. The events resulted in doctor or other healthcare professional office/clinic visit (patient visited dermatologist). Therapeutic measures were taken as a result of itchy redness on arm, chest, stomach and legs included prednisone and hydroxyzine as well as over the counter products PEPCID and ZYRTEC. The clinical outcome of the events itchy redness on arm, chest, stomach and legs and extreme tiredness was not resolved at the time of reporting.    No follow-up attempts are needed. No further information is expected.
Patient reported feeling horrible about 2 hours after the vaccines were given. Noticed redness, swelling and pain in the left arm later on in the day after the injection was given.  Reported having a fever. Went to the ER noticing more swelling, pain and redness a few days after vaccine administration and the ER doctor diagnosed them with cellulitis. Patient's reported complaint was about the Shingrix vaccine.
10Dec03 some stiffness in right elbow that resolved in about 10 days. The following day he noticed stiffness in his lower left leg. 1-1/2-2 days later he had redness, swelling and tenderness just below his left knee that radiated down into his calf and worsens when bending his knee. Denies any weakness of limb. He denies any history of injury or prior trauma. He sought medical care and was treated with Naproxen BID, Tylenol every 4-6 hrs prn, ice and placed on 24hr quarters. He was seen the following day with generalized pain and swelling from boot top up to under left knee cap. U/S to R/O DVT was negative. Symptoms resolved about 2 weeks except for mild TTP at pre-patellar bursa.
Received a #5 DTaP and a #3 Hep B on 5/10 and on 5/11 developed swelling around area on left arm and it was red and hot to touch. As of 5/16/05, there is no more swelling per mom. Also, the hot to touch is gone but there is still some redness.
Agitated that night starting in 4 hours Resolved by am Mild arm pain and febrile sensation during night after injection Myalgia for 3-4 days
body aches, fever 101, reduced to 100;normal p/2-3 days;fatigue;
Numbness of face bilaterally in V1 and V2 branch distribution of trigeminal nerve.
This spontaneous report as received from a nurse refers to a currently 3 months old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions, allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with an improperly stored ROTATEQ lot # N010709 (dose was not provided). Data logger was not involved. No adverse effects were reported. The vaccine was stored in between 9 degrees Celsius (C) to 25 C for 3 hour and 45 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1712USA012873: US-009507513-1712USA012874: US-009507513-1712USA012875: US-009507513-1712USA012877: US-009507513-1712USA012878: US-009507513-1712USA004451.
NASTY SIDE EFFECTS; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 nasty side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nasty side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20211039531.
Vaccine administered 11/19/2001. Symptoms began 11/20/2001; achy, feeling of "coming down with something." Head cold symptoms for 2 days, weakness and pain in all four extremities for 7 days, frequent, spontaneous sweats; minor sore throat and difficulty breathing. Sweats, SOB still present on 12/07.
Red itchy rash in immediate area where shot was administered for 3 days, low grade fever, and lethargic
Tingling in left hand in fingers; Experienced tiredness; Flu like symptoms; Decreased range of motion in left arm/ Is difficult to raise her left arm; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included methotrexate.   On 8th February 2022, the patient received the 2nd dose of Shingrix. On 9th February 2022, 1 days after receiving Shingrix, the patient experienced tiredness, influenza-like symptoms and injected limb mobility decreased. On 13th February 2022, the patient experienced tingling of extremity. On an unknown date, the outcome of the tiredness and influenza-like symptoms were recovered/resolved and the outcome of the injected limb mobility decreased and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the tiredness, influenza-like symptoms, injected limb mobility decreased and tingling of extremity to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and upon following day she experienced tiredness, flu like symptoms and decreased range of motion in injected arm (left arm). She stated that was difficult to raise her left arm. On 13th Febuary 2022 the patient also experienced tingling in her left hand and fingers. Gave medical advice disclaimer. Referred to HCP (Health care professional). Spoke per content. Spoke per PI (package insert). The reporter gave limited information. The reporter consented to follow-up.
Fainting immediately after MENACTRA. This was the third vaccine given. Patient lied flat and recovered completely within 20 minutes.
No adverse effects reported; Medical Assistant gave an unspecified 21 year old female patient VARIVAX subcutaneously in the radial aspect of the arm instead of the outer upper part of the arm; This spontaneous report was received from a nurse referring to a 21 years old female patient. Information about the concomitant medication, pertinent medical history and drug reactions or allergies was not provided by the reporter.   On 25-MAR-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (strength and dose detail were not reported; lot # R002506 and expiration date 25-JAN-2020) which was reconstituted with properly stored sterile diluent, subcutaneously in the radial aspect of the arm instead of the outer upper part of the arm for prophylaxis (product administered at inappropriate site). There were no temperature excursions for the two suspects. No adverse effects were reported.
redness, swelling from shoulder to elbow;tx w/ice, DPH, APAP;
Burning inside nose x 24 h after nasal vaccine. Nausea, vomiting x 24 h after vaccine.
Received Td on 07/06/2010.  By 07/08/2010 Pt could not move R arm at all - went to ER on 07/10/2010 Dx frozen shoulder, very swollen.  Later on 07/10/2010 went to ER because of pain.  Seen by doctor on 07/12/2010, 07/15/2010 seen by neurologist.
Information has been received from a published literature article titled as stated above from Sanofi Pasteur MSD. The patients were vaccined with unspecified hepatitis B virus (HBV) vaccine (dose, route unspecified) on an unknown date. To estimate the incidence of perinatal transmission of hepatitis B virus (HBV) among infants born to hepatitis B surface antigen (HBsAG) positive-mothers and to evaluate risk factors associated with immunoprophylaxis failure. Methods: A retrospective case control study was conducted among HBsAg-positive mother and their infants followed by the Department of Public Health perinatal HBV prevention program between 2005 and 2011 Demographic information was collected from birth certificates and laboratory data within one year pre-and post-delivery from providers and reference laboratories. Results: The number of at-risk infants with post-vaccination serologic testing 9PVST) per ACIP guidelines was low; only 64.9% completed testing. Only 77.2% of these infants were tested at the recommended age of 9-18 months. Among 11,473 infants with PVST, 125 (1.1 %) had immunoprophylaxis failure and developed HBV infection. When 110 infected infants (cases) were compared with 131 randomly selected uninfected infants (controls), case mothers were younger (29.4 vs. 31.4 years, p=0.007), more likely to be foreign born 95.5% vs. 87.0%, p=0.024) and (100% vs. 84%, p<0.001) than control mothers. There was no significant difference in post-exposure prophylaxis (PEP) errors (10.9% of cases vs. 14.5% of controls, p=0.406). case mothers were more likely to have detectable viral load (100% vs. 71.8%, p<0.001), higher median HBV DNA levels (1.4x10^8 vs. 5745.5 IU/mL, p<0.001) and HBeAg positivity (892% vs. 29.0%, p<0.001) than control mothers. Timing of HBV DNA testing was significantly different in case mothers (median 75.5 days after delivery) compared to control mothers (median 36 days prior to delivery), p<0.005 in multivariate logistic regression analysis, maternal HBV DNA level >2x10^7 IU/mL was the only significant independent predictor of immunoprophylaxis failure (OR 40.28, 95% Cl 8.80-184.32). Conclusions: Rates of PVST are inadequate and >10% of at-risk infants have PEP errors. Overall, appropriate PEP provides significant protection and is associated with a low rate of perinatal transmission of HEV. High maternal HBV DNA levels were a significance indicator of risk for immunoprophylaxis failure. Maternal HBV DNA level would be an important prenatal screen if targeted antiviral therapy for high-risk mothers became a strategy to reduce HBV transmission. The outcome of immunoprophylaxis failure was unknown. A  copy of the published article is attached as further documentation of the patient's experienced. Additional information has been requested.
THE PATIENT HAD A PFIZER SHOT 28 DAYS AGO.  WE GAVE HER A MODERNA  SHOT FOR HER SECOND DOSE.  AT 2.5 HRS AND 25 HOURS AFTER THE DOSE SHE WAS ONLY EXPERIENCING A LITTLE BIT OF ARM SORENESS WHICH SHE SAID "IS TO BE EXPECTED"
Swollen, red and painful around injection site, 4 in beyond injection site. Triamcinolone 1% cream prescribed topically.
Slight fever - Elevated blood pressure - Abdominal cramps - Diarrhea - Swelling in left leg with redness and elevated temp. Needed IV antibiotics to fight infection. Treated at ER. Discharged with antibiotics and pain med. and anti-diarrhea prescription meds.
Arm (injection site) is tenderness; fast heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm (injection site) is tenderness) and TACHYCARDIA (fast heartbeat) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Blood pressure high.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm (injection site) is tenderness) and TACHYCARDIA (fast heartbeat). At the time of the report, VACCINATION SITE PAIN (Arm (injection site) is tenderness) and TACHYCARDIA (fast heartbeat) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications are taken for thyroid and high blood pressure. No treatment information was reported.
April 23rd & 24th - bruise and redness around injection site, body aches, stiff neck, headache, joint pain, slight fever, intense fatigue (these symptoms changed every few hours). April 25th-28th - larger bruise/same redness at injection site, moderate fatigue, body aches, stiff neck (symptoms slowly waning); April 29th-May 1st -  bruise gone, redness more pronounced and itching, moderate fatigue, increased appetite; May 1st-May 7th - Intense 2" redness/swelling/itching (like a welt) at injection site, 3" swelling/itching under Left arm (this got severe May 2nd thru May 6th; it was not a lymph node but a large raised/swollen area (no discoloration) and migrated down armpit and into outer Left breast. It was about 20% less on 5/8, and slowly dissipated over the next few days.
Friday night at 9PM patient reports developing "Charlie Horse" on Shins. "Unable to place both big toes on ground." Associate reports both big toes to be contracted upwards, with slight discomfort. Lasted 10 minutes
EMS reported patient with increased BP and flu like symptoms about 30 minutes after injection. Doctor watched her for several hours and said she was fine. I called later and her mother said she was fine.
no other AE reported; expired vaccine administered; This spontaneous report was received from a nurse and refers to a 12-month-old male patient. The patient had no allergies. Concomitant therapies included diphtheria vaccine toxoid, hepatitis b vaccine rhbsag (yeast), pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX), hepatitis a vaccine inact(HAVRIX), influenza vaccine(INFLUENZA VACCINE) and varicella virus vaccine live (oka/merck) (VARIVAX). Medical history included vaccination with 2 doses of pertussis vaccine acellular 3-component, polio vaccine inact 3v (vero), tetanus vaccine toxoid (PEDIARIX).  On 20-OCT-2021, the patient was vaccinated with first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (M-M-R II) lot number: S031483, expiration date: 07-OCT-2021, 0.5 mL one time, subcutaneously for prophylaxis (expired vaccine administered). The patient tolerated the vaccinations well. No additional adverse event was provided.
This spontaneous report as received from a physician refers to a patient of unknown age with egg allergy. On an unspecified date, the patient was vaccinated with 0.5 ml dose GARDASIL (lot # was not reported). No other co-suspects were reported. No concomitant medications were reported. On an unknown date, the patient experienced injection site reaction after getting a GARDASIL. The patient sought unspecified medical attention. No treatment information was reported. At the time of the report, the patient's outcome was unknown. Additional information has been requested.
3/16/2021 Reaction from Pfizer second shot:  I received the second Pfizer vaccine on Tuesday, February 23rd, 2021 around 1PM.  Early Wednesday morning I developed Gastric reflux which I never had before. As the day progressed I had severe abdominal pain that lasted throughout the day, also something I never had before. Nausea set in late that evening. Although Thursday was fairly stable, on Friday I developed black diarrhea that continued all day.  By Sunday I was so weak that a nurse came and sent me to hospital via  ambulance. After 4 days of blood tests, transfusions, a chest x-ray, heart monitor, endoscopy and colonoscopy  etc. , the only diagnosis for the significant blood loss was a bleeding ulcer.  This must have been developing on Wednesday when the severe pain began. After release from the 4 day hospital stay, I was sent to our health clinic for 6 days to regain some strength. Since I never had ulcers, I firmly believe that everything was activated on Tuesday when I received the second Pfizer vaccine shot.  Please advise on your perspective of my situation. Is what I have described similar to others who have reported vaccine side-effects?  Thanks and be well.