chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received a HepB vaccination as an infant but did not complete the series; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 11-year-old patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (on an unknown date received 1st dose as infant ).   On an unknown date, the patient did not receive the 2nd dose of Engerix B. On an unknown date, an unknown time after receiving Engerix B, the patient experienced incomplete course of vaccination (Verbatim: received a HepB vaccination as an infant but did not complete the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 19-JUL-2023 A nurse reported about a patient who received a Hepatitis B vaccination as an infant but did not complete the series.  The reporter did not know if the first Hepatitis B dose was Engerix-B.  The HCP mentioned that they administered Engerix-B to this patient and asked if Engerix-B could be use for catch up.  The reporter declined to share patient information and data regarding the Engerix-B given. Till the time of reporting the patient had not received the second dose of Engerix-B, which led to incomplete course of vaccination.
This report describes the occurrence of arthritis in a 67 year old male who was vaccinated with Lyme disease vaccine recombinant OspA (Lymerix) for prophylaxis. This report was received from the subject and has not been verified by a physician or other healthcare professional.  The subject's medical history and concurrent conditions were not reported.  The subject's concurrent medications reportedly included unspecified vitamins.  The subject reported that he received injections of Lymerix on 04/24/1999, 05/24/1999 and 04/24/00.  He stated, "within a relatively short time thereafter, I was stricken with, what was diagnosed as 'Arthritis'."  The  subject was reportedly seen by a "specialist", who prescribed celecoxib (Celebrex).  The "specialist" reportedly wanted to perform hip replacement surgery.  The subject stated that, after two weeks of celecoxib therapy, "my condition did improve somewhat (I could walk without dragging my foot)." The subject also reported that he began taking "the maximum daily amount" of glucosamine and chondroitin (Osteo Biflex), which "seemed to help".  The subject stated, "Despite all of that, I have, nevertheless, not been able to play tennis or do other things that I enjoy.  Now, (4) years later [sic], I am finding the helpful effects of Glucosamine Chondroitin diminishing and the Arthritis re-asserting itself."
Patient is fully vaccinated.  ED visit on 12/23/2021 and + for COVID. Patient presents to the ED due to concern for COVID - 19. Patient complaining of dry nonproductive cough, headache, generalized myalgias, general fatigue and - "feeling unwell."  Patient states he does have coworkers recently tested positive for COVID - 19.  Denies any shortness of breath. No nausea or vomiting. No abdominal pain. No diarrhea. BP 133/93  | Pulse 105  | Temp 98.2 °F (36.8 °C)  | Resp 18  | Ht 177.8 cm (5' 10")  | Wt 93.9 kg (207 lb)  | SpO2 97%  | BMI 29.70 kg/m²  Cxray: no caute processes. Treatment:  hydration, decadron, toradol, robaxin.  Discharged. Follow up with PCP and cardiology.Patient instructed to come back to ED if symptoms worsen or situation changes.
There was no side effects. We are reporting according to the FDA recommendations, that we should no longer be giving the monovalent  vaccines.
C/o nausea, light headed, dizziness at 13:20.  B/P 136/85, P. 89 Denies respiratory problems.  Face flushed, diaphoretic.  14:00 continued c/o nausea offered.  Vitals 142/81, 78.0  139/89 and 76.  When sat up became pale.  States nausea less sitting-up initially then increased.  14:30 B/P 130/84 P. 74.  Sent home with family
fever, vomited, diarrhea & rash around site & swelling 2" in diameter; duration 48 hrs;
L posterior deltoid-to L arm a red, raised bump size of a pea (1/2 in diameter) -> no drainage, but a center felt to middle red raised area of L posterior deltoid.  No pain or warmth felt or noted to this area.
Soreness and pain at the injection site; This case was reported by a consumer and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in unknown date.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received both doses of shingrix.  The last dose was about 2-3 months ago and starting to had soreness and pain at the injection site.  The reporter asked was this common.
Last Tuesday I was having congestion, fever mild fever, runny nose, and by my performance on Saturday was feeling worse and worse and finally called out of work. I have tested for COVID-19 and that was negative, but this is a horrible cold. I am so tired and achy, and this is really hitting me hard. I have had COVID-19 before, and this feels worse than when I was positive with COVID, and this has been worse than that experience. I also developed pink eye on Sunday as well and think it may be from the runny nose and having a mask.
23OCT95 approx 8PM pt felt fatigued, coughed all noc long;had the chills but no fever; gen malaise; sore throat;h/a, laryngitis;
patient felt lighthead and faint 5 minutes following vaccine adminstration.  Blood pressure 125/79 heart rate 69 , blood pressure repeated 118/84 heart rate 81.  Patient felt fine 10 minutes later and requested no further intervention.
This spontaneous report has been received from a medical assistant, concerning to a multiple unspecified patients of unknown age and gender. No medical history and concurrent conditions were provided.  On an unknown date, the reporter stated that multiple unspecified patients were vaccinated with an improperly stored dose of VARIVAX lot # L034368 and expiration date 08-SEP-2017 (dose and route of administration were not provided) for prophylaxis and was reconstituted with an sterile diluent which did not undergo a temperature excursion. No adverse effects was reported. The vaccine was stored at a total time in the range of temperature -9°Centigrade to 8° Centigrade, time frame of 37 minutes, no previous temperature excursion was reported. The call was placed because of a Digital Data logger report. Product quality complaint was not involved. Additional information has been requested.
Information has been received from a physician concerning a 17 year old female who on 12-MAR-2008 was vaccinated with her first dose of GARDASIL (lot # and site unknown).  On 18-MAR-2008 the patient "fainted before she left the office".  The patient sought unspecified medical attention.  No further information was provided.  Additional information has been requested. This is a follw-up to the report (s) previously submitted on 4/14/2008. Initial and follow up information has been received from a physician concerning a 17 year old femal, with a history of a syncopal episode (approximately 2006) and with mild anemia, who on 12-MAR-2008 was vaccinated intramuscularly in the right arm with her first dose of GARDASIL (lot # 659180-1758U). Concomitant theroy included vaccination in the left arm with a first dose of VARIVAX (Oka/Merck) (Lot # reported as1656U). On 12-MAR-2008 the patient "fainted before she left the office". The reporter indicated the patient's mother was contacted on the night of 12-MAR-2008, and the patient had recovered. The patient had mild anemia and on 14-MAR-2008, the patient had a CBC, ferritin and TRH testing which were normal. No additional informaton is expected.
Redness and swelling at injection site.  Approx. 6 inch diameter.
I woke up Sunday morning (11/21/2021) at 6:00 AM with a red bumpy rash that was on my lower back that was itchy and painful if I did not itch it. I went ahead and drove to work where it began to spread up my back, and to my arm. Over the last two days (11/22/21-11/23/21) the red rash has spread to my upper back, hips, abdomen, chest, neck, and extremities. I was prescribed a Medrol pack by Doctor on Sunday (11/21/2021) and started as soon as I got it. I have also been taking Benadryl to reduce the amount of spreading, and will also be starting the antibiotic  Dicloxacillin when the pharmacy has it in stock (its been delayed due to not being in stock).
red rash; bruise; slight nausea; slight feeling of fever but temp registered normal; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number BNT162b2), at age of 59-year-old via an unspecified route of administration in left arm on 31Dec2020 11:00 at single dose for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID), valsartan, rosuvastatin (ROSUVASTATIN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. The patient was not pregnant at Time of Vaccination. The patient experienced red rash, bruise, slight nausea, slight feeling of fever but temp registered normal on 12Jan2021 01:00 with outcome of recovering. The patient received topical antibiotic, diphenhydramine (BENADRYL) for treatment. The events resulted in doctor or other healthcare professional office/clinic visit.
patient was vaccinated with adacel which was not viable due to delayed transit, no AE; patient was vaccinated with adacel which was not viable due to delayed transit, no AE; Initial and additional information was received on 31-Dec-2019 regarding an unsolicited valid non-serious case from a consumer/non-hcp (office staff).  This case involves a 37 years old male patient who was vaccinated with a 0.5 ml dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot: U6602AA, expiry date: 25-Feb-2022) via intramuscular route at right deltoid on 28-Dec-2019, which was not viable due to delayed transit.   Medical history, past medical treatment, past vaccination and family history were not provided.  Concomitant medications included INFLUENZA VACCINE INACT SPLIT VIRION 4V (FLUZONE QUADRIVALENT) on 28-Dec-2019 for Immunisation.  It was an actual medication error due to incorrect product storage and product shipment delay.  At the time of reporting, the patient did not experienced any adverse event.  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 Directive and Module VI of the 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.
Patient presents with raised bumps arms, trunk, and thighs x 1600. First noticed on L shoulder and has spread since. J&J vaccine today at 0830. Patient denies pain, trouble breathing, fever, or CP. Patient took 1000mg tylenol at 1145.
PATIENT DESCRIBES FOR 2 DAYS, BOTH OF  HIS HANDS WERE PAINFUL, NUMB, AND STIFF. HE COULD NOT GRIP ANYTING. ie. HE TRIED TO PICK UP A BOTTLE / GLASS AND IT SLIPPED OUT OF HIS HANDS .
This spontaneous report was received from a registered nurse and refers to 2 unspecified patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 12-MAY-2017, the patients were vaccinated with doses of improperly stored VARIVAX lot # M032493 with expiration date on 06-JUL-2018 (dose and route of administration were not reported). The vaccine underwent a temperature excursion of 13 degrees Fahrenheit for 9 hours. Digital data logger was used to record the excursion. The vaccine underwent previous temperature excursion of 7 degrees Fahrenheit for 17 hours and 30 minutes. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1706USA002688:
CHILD RECEIVED INCORRECT PFIZER FORMULATION FOR AGE GROUP. RECEIVED ADULT PFIZER FORMULATION. SHOUL'DVE RECEIVED THE 5-11YO FORMULATION.
Vaxelis inadvertently given as 12 month dose. No patient harm or reaction to this vaccine.
Patient received Pneumovax 23 on 10/09/2003 in right thigh.  By the next day, entire lower leg/knee on that side swollen to size of large orange; also red/warm.  No obvious infection.  Initially patient limping; seen today and now ambulatory normally end swelling about gone.
pt received 0.2 dose undiluted form of Pfizer pediatric vaccine.  pt is currently doing well beside slight fever and mom gave Tylenol.
On my way back to home I looked at the clock it is 10:38AM when I saw my face really flushed in the mirror and started feeling that I could not feel tongue, inside the mouth was also numb and tingling, my gums and tongue and cheeks and lips. Got home and went to bed  around 11AM and woke up at 2PM feeling worse the numbness now was going down my throat, like it was swelling. Took 25 mg of Benadryl and called my PCP who advise to go to the ER. At the ER they did a CBC  and a CMC or a CMB not sure. They also gave me 15mg of IV Benadryl and 8 mg of IV Decadron. About 15 min after receiving the IV meds at the ER I started feeling relief.  Around 8PM I was released to go home.  No symptoms next day.
High fever. x 1 day T max 103. Fever at office 105 rectal. Pt is irritable and cranky. Patient referred  to hospital ER for further evaluation on f/u phone call made to parents - baby's feer is ok now 12/1/15.
Pt states hours after receiving the vaccine he started having chills and vomited for several hours. He reports having these symptoms in the past after receiving the flu vaccine. Advised pt to discuss future administration w/PCP.
Pt developed a tingling sensation in upper extremities, administered O2 NC 4L EKG-normal sinus, vitals; BP 126/84; Pulse-81; SPO2 - 95% RA.
Information has been received from a pharmacist concerning a 71 year old female with an allergy to lipstick, heart disease congenital, high blood pressure and a history of cholesterol levels raised and breast cancer, who on 19-JUN-2008 was vaccinated with 0.5 ml of PNEUMOVAX 23 (lot# 659150/1384U). It was unknown if this was the first or second dose. Concomitant therapy included LOTREL, TAXUS and ATENOL. On 20-JUN-2008 the patient experienced swelling at the injection site of her arm. Unspecified medical attention was sought during office visit. It was reported that the patient was treated with unspecified antibiotic. The patient's swelling at the injection site persisted. No additional information is available. No additional information is expected.
Breakthrough case admission after 2 vaccines Pfizer 2/1/21 Lot# EL9265;  Pfizer 2/22/21 Lot# EN6200
Patient received vaccination before the recommended minimum age.  Mother of Patient filled out paperwork and documented that the patient was 5 years old.   When the mother was asked why she documented that patient was 5, she said she wanted patient to receive vaccine.
Severe Pounding Headache; Red patch at the injection site that felt warm to touch; Swelling of arm (left) she received injection in; Loss of appetite; FEVER; CHILLS; This spontaneous case was reported by a pharmacist and describes the occurrence of DECREASED APPETITE (Loss of appetite), PYREXIA (FEVER), CHILLS (CHILLS), HEADACHE (Severe Pounding Headache) and VACCINATION SITE SWELLING (Swelling of arm (left) she received injection in) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced DECREASED APPETITE (Loss of appetite), PYREXIA (FEVER), CHILLS (CHILLS) and VACCINATION SITE SWELLING (Swelling of arm (left) she received injection in). On 29-Mar-2021, the patient experienced HEADACHE (Severe Pounding Headache) and VACCINATION SITE ERYTHEMA (Red patch at the injection site that felt warm to touch). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 28-Mar-2021, PYREXIA (FEVER) and CHILLS (CHILLS) had resolved. At the time of the report, DECREASED APPETITE (Loss of appetite), HEADACHE (Severe Pounding Headache), VACCINATION SITE SWELLING (Swelling of arm (left) she received injection in) and VACCINATION SITE ERYTHEMA (Red patch at the injection site that felt warm to touch) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) is considered as not applicable.
arm was sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm was sore). The outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 This case was reported by a patient via interactive digital media. The patient stated that the vaccine was not as bad as everyone said it was, by far his or her arm was sore for a few days. Follow-up was not possible, as no contact details were available.
Hypertensive  and headache after vaccination and sent to ER. Has history of hypertension and takes medication or this.
pt recvd vax;devel severe pain accompanied by swelling & inflam at inject site;
Vaccines administered 8/6/08. 8/7/08 developed rash and seen by MD. Rash on back small pimple raised vesicles/papular. No fever. Rash resolved 8/11 (moving to a foreign country 1 yr).
Tenderness; Electric current on left side of neck and shoulder; A spontaneous report was received from a consumer, concerning a 81 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced tenderness and electric current on left side of neck and shoulder.  The patient's medical history reported includes thyroid removal. Concomitant medications reported includes Synthroid, Lexapro and Atorvastatin.  On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.  On 14 Jan 2021, the patient experienced tenderness and electric current on left side of neck and shoulder. Treatment medications reported includes Advil once daily on 15 Jan 2021 and 16 Jan 2021.  Action taken with mRNA-1273 in response to the events were not reported.   At the time of this report, the outcome of event tenderness was considered resolved. The outcome of the event electric current on left side of neck and shoulder was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  Further information has been requested.
Twenty three hours after my first vaccine I had intense burning headache suddenly come on and I started to feel very fatigued.  I finished my work, drove home and for the next day in  a half I was tired and had headaches off and on. Took aspirin , pushed fluids and rested for the rest of the weekend.  Symptoms eventually went away.
Pt developed a vesicular rash on 3/29/00 and continued to spread.
Body aches; Chills; Headache; This is a spontaneous report from a contactable consumer (patient herself). A 63-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9267), via an unspecified route of administration in right arm on 16Feb2021 at 16:30 as a single dose for COVID-19 immunisation. The patient's medical history included 20-year breast cancer survivor, no chronic health conditions, COVID-19 from 26Jun2020 (when patient had COVID, 26Jun2020, patient had these same symptoms plus a low fever, but patient was sick much longer), allergy to Sulfa based meds (allergies to medications, food, or other products: Sulfa based meds), low fever, sick. Concomitant medications included clarithromycin (CLARITIN), acetylsalicylic acid (ASPRIN) at 84 mg, multi-vitamin; All received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that, 24 hours after dose, on 17Feb2021, the patient experienced body aches, then chills and headache for the next 8 hours. Recovered fully. The second dose was scheduled on 09Mar2021. The patient underwent lab test and procedure which included body temperature: Low fever on an unspecified date in 2020. The events were considered as non-serious by the consumer. No treatment medications were received for the adverse events. The outcome of the events was recovered on an unspecified date in 2021.