chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient only received the 0.4 Sodium Chloride diluent portion, the powdered ActHIB was not added to it; Initial information received on 11-Jun-2019 regarding an unsolicited valid non-serious case received from other health professional via phone.  This case involves a patient of an unknown demographics who only received the 0.4 Sodium Chloride diluent portion, while he/she received a dose of HIB (PRP/T) VACCINE [ACT-HIB] (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   It was a case of actual medication error due to inappropriate reconstitution technique because patient only received the 0.4 Sodium Chloride diluent portion, the powdered ActHIB was not added to it.  It was unknown if any adverse event occurred or not following the vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.   Information on the batch number was requested.  Documents held by the sender: none.
Doses administered past the published expiry date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date). On 13-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No Treatment Information was provided by the reporter.
Breakthrough Covid positive case; Breakthrough Covid positive case; This is a spontaneous report received from a contactable reporter(Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Oct2021 (Lot number: EW0217) at the age of 46 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 09Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 21Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. No covid prior vaccination. No other vaccine in four weeks. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 06Mar2022, outcome "recovering" and all described as "Breakthrough Covid positive case". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (07Mar2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19.
Tongue swelling and palpitations and difficulty with speech and swallowing, and throat tightness.  onset within 30 minutes of vaccines.  taken to Urgent care, received epinephrine injection, then transferred by ambulance to  Hospital ER.   given IV diphenhydramine and IV decadron.  chest pain.  normal ECG and troponin.  They did not check tryptase.
Vaccine given 3:30pm approximately 1hr after receiving vaccine severe (L) arm pain that radiated up to left side of neck. Pain affected use of arm for 36 hrs. Had to take VICODIN to help control pain unable to sleep due to pain.
Initial information received on 10 May 2007 as a result of a literature abstract that was acquired secondary to the report from a patient's parent (separately reported case). Per the citation, "We describe four cases of leucocytoclastic vasculitis following influenza vaccination. The four patients, who were all elderly, presented with cutaneous vasculitis but all had abnormal urinalysis suggestive of associated renal involvement." Additional information was not reported. The reporter in this case is the same as for case 2007-01692.
DIZZINESS, NAUSEA, SHORTNESS OF BREATH  WITHIN 15 MIN OF INJECTION
Sore throat (started 3/20/13 AM). Lt. side neck (glands) swollen & tender, 3/20/13 (start AM). Lt. earache (started 3/20/13 AM). Low grade fever (started 3/19/13 PM).
Patient experienced "pressure on heart and unable to breathe" 2-3 hours after receiving the vaccination.  It lasted 2-3 hours.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies and medical history provided. On 02-NOV-2016, the patient was vaccinated with the first dose of Gardasil 9 (exact dose, route of administration, lot # and expiration date were not provided). On 15-AUG-2016, the patient received the second dose of GARDASIL 9 (lot # M009116, expiration date: 13-JUN-2018), which was outside the recommendations per the Gardasil 9 prescribing information. No adverse effects were reported. Additional information has been requested.
Controlled BP jumped to 180/110 causing GFR to go from 35 down to 19 in a couple of weeks, leveling out at GFR of 13.
She described to be already very sick from COVID; She described to be already very sick from COVID; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A 70-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "celiac disease" (unspecified if ongoing), notes: caller mentioned that she has the celiac disease. 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 "She described to be already very sick from COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: very sick from COVID.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the available information in the case, an association between the reported events and bnt162b2 cannot be ruled out.  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. ,Linked Report(s) : US-PFIZER INC-202201206645 Same patient/drug/event, different dose;
Patient received a high dose fluzone by accident.  He was suppose to receive his Boostrix vaccination and he already received his flu vaccine in August.  He is 58 years old and received the high dose vaccine that was filled for his father in law that was with him at the time.  I spoke with patient today and he has had no emotional issues or physical issues due to this incident.
Information has been received from a physician concerning 20 - 27 year old females who were vaccinated with Gardasil. Subsequently 99% of her patients were saying that Gardasil vaccination is the most painful than any other vaccine. Patients were tearing up because the vaccination was so painful. The patient's outcomes were not reported. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been requested.
Right arm red, swollen 3 x 4 in. warm to touch. Reminded father to apply cold pack every 2 hrs. for 10-15 min for 24hrs. then warm pack after 24hr. and call if not better after 24 hrs.
This spontaneous report as received from a pharmacy technician concerning a currently 3 years old child. Gender was not reported. Medical history and concurrent conditions were not reported. On 27-MAR-2014, the patient was vaccinated with VARIVAX (Merck) lot #J007955; expiration date: 27-JUN-2015, (dose, strength and route were not reported). Secondary and concomitant therapies were not reported. Patient was vaccinated with VARIVAX (Merck) that was exposed to 43.1 degrees F for 29 hours on 03-MAR-2014. This is one of several reports from the same reporter. Additional information has been requested.
Swollen at the injection site; Red at the injection site; Left jaw felt weird; This spontaneous case was reported by an other and describes the occurrence of JAW DISORDER (Left jaw felt weird), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included Lupus erythematosus systemic since an unknown date. Concomitant products included OXYMETAZOLINE HYDROCHLORIDE (CLARITIN ALLERGIC), ACETYLSALICYLIC ACID (ASPIRIN 81) and FLUTICASONE PROPIONATE (FLONASE ALLERGY RELIEF) for an unknown indication.    On 26-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 03-Apr-2021, the patient experienced JAW DISORDER (Left jaw felt weird). On 04-Apr-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red at the injection site). On 05-Apr-2021, the patient experienced VACCINATION SITE SWELLING (Swollen at the injection site). At the time of the report, JAW DISORDER (Left jaw felt weird), VACCINATION SITE ERYTHEMA (Red at the injection site) and VACCINATION SITE SWELLING (Swollen at the injection site) outcome was unknown.            Concomitant medication of cholesterol medication is stated in report.
About 17 hours after event, I began vomiting. I vomited 4x in 4 hours. Could not keep fluids down. Physically uncomfortable. Chills and sweats. Mild fever. I went to the emergency department of my local hospital. Was given fluids and anti-nausea meds.  I had the same experience with my first booster in November, 2021.
No additional adverse events.; On 1/3/2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant, referring to a 7-year-old patient of unknown gender. The patient's concurrent conditions, pertinent medical history, and previous drug reactions or allergies were not provided.  On 03-JAN-2020, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, vaccination scheme, route of administration, and anatomical site of vaccination were not reported; lot number S006018 has been verified to be a valid lot number, expiration date reported and validated as 27-FEB-2021) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK) (lot number and expiration date were not reported).     The administered dose of varicella virus vaccine live (oka/merck) (VARIVAX) experienced a temperature of 15 degrees Fahrenheit (F) to 46 F (36.86 F) during a time frame of 9 hours and 49 minutes. In addition, previous temperature excursion of 15 F to 46 F (19.13F) during a time frame of 1 hour and 30 minutes. No data logger was involved. No adverse events were reported.
Cellulitis (L) arm. Follow up with provider 10/20/15 to re check. Tx with cephalexin 250 mg/5 ml bid x10 days.
Depression; Body aches; Ache at the site of injection; Mild nausea; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm right on 13Mar2021 at 09:45 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included breast feeding. It was reported that breastfeeding could be considered chronic and the patient was an abnormally healthy person, doesn't get sick often. Concomitant medications included prenatal vitamins(MANUFACTURER UNKNOWN). The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208) via an unspecified route of administration in the arm left on an unknown date as a single dose for COVID-19 immunisation. 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. On 13Mar2021 at 10:00, 15 minutes after vaccination, the patient experienced depression, general body pain, vaccination site pain and nausea. The patient had depression, body aches, ache at the site of injection and mild nausea. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. The clinical outcome of the events depression, general body pain, vaccination site pain and nausea were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a now 75 years old female patient. The patient had no pertinent medical history or drug allergy. In 2007 the patient was vaccinated with ZOSTAVAX, 0.65 ml single injection, subcutaneous. In 2012, "about a year ago", the patient experienced a single, red quarter-sized rash on her face. The patient went to the doctor, who prescribed ZOVIRAX for the rash. The doctor told her she had shingles, based on her clinical experience, but no lab tests were performed. The rash went away about a month later, approximately in 2012. The outcome of event was recovered. Additional information has been requested.
Patient said shortly after her vaccine, not at the injection site, but from her wrist to her elbow, her muscles were really sore and hurt. She said she thought it was strange and wanted to report it. She said that it cleared up by the evening and did not come back.
J18.9 - Pneumonia CHEST PAIN SHORTNESS OF BREATH FEVER VOMITING
Rashes on the body, started with rashes at neck. The rashes are very itchy
20-year-old AD male who reported onset of substernal, sharp chest pain with mild dyspnea (noted when going up stairs). Self treated with Ibuprofen without significant change in CP Sought evaluation on 30 Mar - Chest Pain (6/10), worse with deep breaths and while lying supine. No radiation; no worsening of CP with exertion. Also, reports frontal headache; describes as "pressure" type pain. VS at presentation - 124/92, 111, 12, O2 Sat 99, T 100.4 Physical exam notes pericardial friction rub; no other abnormalities No cough, no rashes, no dizziness. Mention of abdominal pain, but no N/V/D; tolerating foods Placed on light duty and changed Ibuprofent to Naproxen 500mg twice/day. 1 Apr 2021, Follow-up - still reports CP (8/10), also reports mild dyspnea and headache. Afebrile. No mention of friction rub. Naproxen changed to ibuprofen 800 mg 3x/day.  5 Apr 2021, Follow-up - still with CP(6/10), mild dyspnea and headache. Fevers and abdominal pain resolved. PE noted faint friction rub. Added Colchicine 0.6 mg 2x/day. Continued on light duty. 20 Apr 2021, Follow-up - Notes some improvement with colchicine but feels pain over heart throughout day at random times,(6/10); continues to 'hurt to breathe'. Continues to report headaches that decrease with Ibuprofen, but pain reduction only lasts a couple hours.  Exam 'no friction rub'. Per Cardiology recommendation, decreased Ibuprofen to 2x/day, continue Colchicine x 3 months, MRI before colchicine discontinued (July). Continues on light duty. 20 Jun - still having chest pain. Cardiac MRI ordered, but not visible in records on 28 Jul
On 11/24/14 came to office with rash of 2 days dx of herpes zoster treated with Acyclovir 200 mg/5 ml, 10 ml tid x 5 days. Returned to office 12/3/14 with history of bruising for 2 days-CBC revealed critically low platelet count-admitted to hospital.
approx 2hr p/vax had thickening of tongue;thirst approx 3hr p/vax;itching;completely covered w/red blotches & welt;seen by MD;itching started 4-5hr p/vax; next day rash about gone;
screaming > 3 hr p/vax; hx obtained 30MAY95;
10/29/02 had a seizure, was admitted to hospital and had a seizure the following day. CT positive for sinusitis. EEG abnormal. Pt placed on Dilantin. Add vomiting x 2. Add lethargy.
Burning sensation around heart. Similar to a pulled muscle, but when I rub my left side i dont feel anything from the exterior. The pain feels deep inside like my heart is swollen.
This spontaneous report was received from a Licensed Practical Nurse concerning an unspecified number of patients of unknown age and genders. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On unknown dates, the patients might have received improperly stored doses of VARIVAX (lot number M035142, expiration date 03-AUG-2018, dose and route were not reported) for prophylaxis. The temperature exposure was from 14°F to 46°F for 3.5 hours (210 minutes). A data logger was involved and there was no previous temperature excursion. No adverse effects were reported. A product quality complaint was not involved. This is one of two cases reported from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA009130.
102 fever, dizziness, vertigo, chills, neausea, muscle pain, horrible headache, head stiffness
CRP reactive protein level was over 10; Discomfort in her right arm around the injection site; This case was reported by a consumer and described the occurrence of injection site discomfort in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). In November 2020, 1 min after receiving Shingrix, the patient experienced injection site discomfort. On 14th December 2020, the patient experienced c-reactive protein increased. On an unknown date, the outcome of the injection site discomfort was recovered/resolved and the outcome of the c-reactive protein increased was unknown.   It was unknown if the reporter considered the injection site discomfort and c-reactive protein increased to be related to Shingrix.  Additional details were provided as follows: The patient had reported the case for herself. The patient received vaccine on her right arm around 3 weeks ago from the reporting date. The patient was unsure of the exact date of vaccination if it was 20th or 21st  November 2020 and did not have lot number or expiration date of vaccine. The patient reported that from the minute she received the vaccine she had discomfort in her right arm around the injection site and this lasted for 3 days and resolved in November 2020. The patient went to have blood work drawn on monday 23rd November 2020 and found out on 14th December 2020, less than a month after vaccination that her C-reactive protein level was over 10 and her doctor told that a value for C-reactive protein over 10 was extremely high. The patient would have blood work done again in 3 weeks to recheck the C-reactive protein level. The patient gave consent to follow-up with her health care professional.
Fever; soreness in his arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in his arm) and PYREXIA (Fever) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002b21a) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TETANUS VACCINE (Patient stated that on the 16th of Feb he had a tetanus injection.) on 16-Feb-2021.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in his arm). On 10-Mar-2021, the patient experienced PYREXIA (Fever). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (soreness in his arm) and PYREXIA (Fever) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Mar-2021, Body temperature: 101.5 degree f High.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
HIGH FEVER (102), BODY ACHES, NAUSEA, CHILLS, MIGRAINE, ARM PAIN. THE SYMPTOMS CAME ON GRADUALLY OVER THE FIRST 24 HRS AND THEN STARTED TO DISSIPATE AFTER ABOUT 36 HRS AND WERE COMPLETELY GONE IN 48 HRS. TOOK ADVIL. SLEEP.
Patient complains of rash on right arm. patient received shingrix injection on 3/15/18, states about ten days after injection , he  noticed a burning sensation in right arm lasting about until 3/30/18, once the burning stopped he noticed a rash on arms and back on right side with the appearance of a pattern. Pt seen by MD who prescribed Acyclovir for possible shingles
PATIENT RECEIVED COVID VACCINE MIXED WITH BACTERIOSTATIC 0.9% NORMAL SALINE INSTEAD OF PLAIN NORMAL SALINE 0.9%
I'm sorry I don't know the specific vaccine, but it was the flu vaccine for the 2017/2018 flu season. I had the standard ache and drowsiness for 2 days following the shot. But 1 week and 2 days later, the arm pain has changed and worsened. I now have on and off muscle pain at the site of the injection. I can move my arm without issue, and I haven't been able to identify the trigger for the pain to start/stop. The pain is mild to moderate (up to a 4 out of 10 on the pain scale) and the pain seems to increase when I use my fingers for anything dexterous, like typing. At this point, I have not been able to identify anything to alleviate the pain.
Mom describes infant awoken from nap and refused to feed and was then noted to be pale, limp, unresponsive, eyes slightly cloased-episode lasting about 5 min. Ambulance called, infant taken to local ER.  At time of arrival, infant acting normal, responsive, eager to feed.  Fever 101.9 noted in ER.  All lab within normal limits.  Infant discharged home with follow up in office.  No further episoes of unresponsiveness.  No further fever.
Had horrible reaction to both shots that included vomiting, diarhea, severe abdominal, joint and muscular pain.  Developed new-onset System Lupus after receiving these injections.  NO FAMILY HISTORY OF LUPUS OR OTHER SIMILAR DISEASES.  Also found latent Tuberculosis given to me from my coworkers who travel to and from another country with horrible respiratory conditions and refuse medical treatment because they feel the physicians are not smart enough.