chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had the shot and shingles / Suspected vaccination failure; AFib; Shingles; Takes all energy, drained; Had worse pain, extremely painful, still have pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: Had the shot and shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), atrial fibrillation (Verbatim: AFib) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), energy decreased (Verbatim: Takes all energy, drained) and pain (Verbatim: Had worse pain, extremely painful, still have pain). The outcome of the vaccination failure was unknown and the outcome of the atrial fibrillation, shingles and energy decreased were not reported and the outcome of the pain was not resolved.  It was unknown if the reporter considered the vaccination failure, atrial fibrillation, shingles, energy decreased and pain to be related to Shingrix.  It was unknown if the company considered the vaccination failure, atrial fibrillation, shingles, energy decreased and pain to be related to Shingrix.  Additional Information: GSK Receipt Date: 01-APR-2023 This case was reported by the patient via interactive digital media.  The reporter stated that he/she had the worse pain and had Atrial fibrillation (AFib) and shingles the same time. The pain was extremely painful and takes all your energy drained. The pain had lasted for more than two months, still had some pain and he/she had the shot but guess it was wearing out. The reporter prays that you did not get it. What was shingles worse than, for him/her, it was worse than getting a root canal.  The pain was so intense. This Shingles awareness week, tell him/her what else shingles was worse than. Let someone over 50 know, so they could be informed about how painful shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Around Monday the 12th after receiving the vaccine my lymph nodes on the rise side of my head and face were very swollen.  The 13th I started to notice bumps on my head, and face.  14th weds felt ill and warm, woke up with a fever.  Got tested for covid the morning of the 15th.  Went to urgent care that afternoon and was diagnosed with shingles on my face, eyelid, and scalp.   Prescribed valtrax for 7 days started the 15th, gabapentin a day later for the pain, 400 mg advil, 1000 mg Tylenol.   Lesions are now healing.
left sided cervical and lymphadenopathy for 10 days that self-resolved. Lymph nodes from neck up to left side of scalp including left eye lid were inflamed with serous draining and erythematous lesion that caused mild to moderate pain.
This initial spontaneous report was received from a healthcare professional referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concomitant medications or drug allergies/drug reactions described.  The reporter stated that on multiple unspecified dates, the patients were administered improperly stored doses of VAQTA injection (lot # K018181 with expiration date 04-JUN-2017; dose and route were not reported). No adverse effects were reported. It was unknown if the patient's sought medical attention. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Headache within 30 min. of shot.  2 hrs. after shot felt poor.  Within next 4 hours, eyes got red, lip swelled, fever, chills, tremors, pressure in chest, heart pounding hard and could fell it beating in her legs.  Throat sore.  Took Motrin and went to bed 6 hours after shot and went to bed.  Better in AM.
Back pain, arms and legs felt tingling. Fever recorded 102 degrees, Discharged with diagnosis of viral illness/ poss. vaccine reaction.
Moderna yellow cap 0.2mL/10ug  given instead of higher dose of Moderna bivalent 0.25mL/25ug
Pt. said" Yesterday morning he started with feeling fatigue, then Headache, then Nausea, He took tylenol and his symptoms were less, then woke this morning with Numb and tingling left arm, so went to urgent care facility.
Symptoms included shortness of breath, chest pain and hives (rash) with in an hours of receiving the vaccine.
Dizziness the night of the injection, and then pronounced vertigo  for a week whenever in a prone position. Extremely painful left arm for 3 days. Residual soreness for several weeks. Flu-like feelings for 3 days. Rash on the injected arm which appeared one week later-- 4" by 3".
Fast racing heart; the sensation that she had too much medicine; tingling; Bell's palsy; mild fever; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Fast racing heart), FEELING ABNORMAL (the sensation that she had too much medicine), PARAESTHESIA (tingling), BELL'S PALSY (Bell's palsy) and PYREXIA (mild fever) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Fast racing heart), FEELING ABNORMAL (the sensation that she had too much medicine), PARAESTHESIA (tingling), BELL'S PALSY (Bell's palsy), PYREXIA (mild fever) and NAUSEA (nausea). At the time of the report, PALPITATIONS (Fast racing heart), FEELING ABNORMAL (the sensation that she had too much medicine), PYREXIA (mild fever) and NAUSEA (nausea) outcome was unknown and PARAESTHESIA (tingling) and BELL'S PALSY (Bell's palsy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient had a prescribed medication but used to take it when necessary.  After first vaccination, patient had a fast racing heart, mild fever, nausea and the sensation that she had too much medicine for a few days. Two moths later she developed bell's palsy and tingling.  Treatment medication included steroids for tingling.  Company Comment: This case concerns a 38-year-old female patient, with no reported medical history, who experienced the unexpected events of Palpitations, Feeling abnormal, Paraesthesia, and the expected events of Bell's palsy (AESI), Pyrexia and Nausea. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.   This case was linked to MOD-2021-419552 (Patient Link).; Sender's Comments: This case concerns a 38-year-old female patient, with no reported medical history, who experienced the unexpected events of Palpitations, Feeling abnormal, Paraesthesia, and the expected events of Bell's palsy (AESI), Pyrexia and Nausea. The events occurred on an unknown date after the first dose of mRNA-1273 Vaccine. At the time of the report the outcome of the events was unknown. The rechallenge was not applicable as the events occurred after the first dose. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
COVID-19 symptoms, congestion; cough; low grade fever 100.0; burning sensation in my sinuses. As of today I am still feeling tired; have a lingering cough; fatigued and continue to have issues with my sinuses. I have a follow up scheduled tomorrow with my primary care physician.
This spontaneous report was received from a nurse from the physician's office via a Company representative, referring to a patient of unknown age and gender. The patient's pertinent medical history or concurrent conditions were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot#, dose, frequency and route of administration were unspecified) for prophylaxis. Concomitant therapies included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid and meningococcal vaccine (unspecified). On an unknown date after receiving GARDASIL 9, the patient became lightheaded but did not pass out while she was at the physician office. It was reported that no intervention to prevent serious criteria was necessary, that dizziness was not significant disability or incapacity or life threatening, and that the patient was not hospitalized. No product quality complaint was involved. At the time of the report, the outcome of dizziness was reported as recovered on an unspecified date. The relatedness assessment between GARDASIL 9 and dizziness was not provided. Additional information is not expected since there is no consent from the physician to be contacted.
reconstituted with sterile water instead of with the adjuvant AS01B; reconstituted with sterile water instead of with the adjuvant AS01B; This case was reported by a pharmacist and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2021, the patient received Shingrix. On 8th July 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at the vaccination was not reported. The patient had taken Shingrix but the vaccine was reconstituted with sterile water instead of with the adjuvant AS01B which led to wrong solution used during drug reconstitution and inappropriate dose of vaccine administered. The reporter did not have any information regarding patient's demographics or vaccine information (lot number and expiration date) on call and was not on the same facility were the event happened. Pharmacist did consent to follow up by email.
The first dose did not cause any adverse symptoms.  The second dose took effect on me by about midnight. I had chills, the a fever and body ache. I slept all day Friday and all night. My fever was at 100.8  I just stayed in bed.  Today I am better.
The patient noticed swelling and redness at the site of the injection on the left arm on the same day of the vaccination. This area continued to grow and became very pruritic over the next 3 days. On the day of exam there was a 10 cm area of erythema & 4 cm induration.
Information has been received from a physician concerning a 11 year old (also reported as 10 year old) male patient who on 01-DEC-1999 was vaccinated with his first dose of MMR II and on 09-DEC-2002 was vaccinated with his second dose of MMR II. On 30-DEC-2009 the patient experienced the onset of mumps. Diagnosis was made on 31-DEC-2009, the patient's signs and symptoms included Left parotitis. The patient was reported as afebrile. Diagnostic laboratory tests performed on 31-DEC-2009 included: IgM < 1:10 and IgM: 3.75. Additional information is not expected.
mom called 27OCT95 states site red & swollen-rec cool compresses x APAP;call to phone triage 28OCT 7PM groin to knee sl swollen w/blue areas-ER MD ? cellulitis
Started with normal fatigue headache and sore arm then fever to 102, spiked to 104 tuesday evening, shot done monday.   Fever back to 102 for a day.  Today friday lowgrade fever, sore throat/swollen glands, headache and still extreme fatigue.
devel raised rash starting on lt thigh;rash progressed over 24hr to trunk areas itchy;parent called MD DPH ordered;6/4/99 rash completely gone;no adverse effects;no HIB needed in the future;
Unsure of exact onset, but patient came back 2 days later with redness below the injection site which she stated was hot to the touch.
She had soreness a little bit; she got sick; she felt crappy; tired; Today her stool is harder and not as liquidy; diarrhea; she developed diarrhea with the continuing headache; dizziness/dizzy; nausea/nauseous; headache; didn't feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 28Mar2021, outcome "unknown", described as "dizziness/dizzy"; NAUSEA (non-serious) with onset 28Mar2021, outcome "unknown", described as "nausea/nauseous"; HEADACHE (non-serious) with onset 28Mar2021, outcome "unknown", described as "headache"; MALAISE (non-serious) with onset 28Mar2021, outcome "unknown", described as "didn't feel well"; FAECES HARD (non-serious), outcome "unknown", described as "Today her stool is harder and not as liquidy"; DIARRHOEA (non-serious) with onset 29Mar2021, outcome "unknown", described as "diarrhea"; HEADACHE (non-serious) with onset 29Mar2021, outcome "unknown", described as "she developed diarrhea with the continuing headache"; PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "She had soreness a little bit"; ILLNESS (non-serious), outcome "unknown", described as "she got sick"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "she felt crappy"; FATIGUE (non-serious), outcome "unknown", described as "tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
W/in 24 hrs p/vax immun, infant experienced a fever of 105.3 & an inject site react consisting of pain, swelling, increased warmth & induration w/o abscess. sx lasted 2 days.
patient got the flu; Initial information was received on 07-Nov-2020 regarding an unsolicited valid non-serious case from a social media via consumer or non-health care professional.  This case involves female patient (age unspecified) who experienced flu (influenza), while she received INFLUENZA VACCINE [Flu shot].   Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was unknown for event.   There will be no information available on the batch number for this case.
itching real bad injection site; soreness on the injection site; redness on the injection site; hardness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness on the injection site), VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE INDURATION (hardness on the injection site) and VACCINATION SITE PRURITUS (itching real bad injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SL20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (soreness on the injection site), VACCINATION SITE ERYTHEMA (redness on the injection site) and VACCINATION SITE INDURATION (hardness on the injection site). On 14-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching real bad injection site). At the time of the report, VACCINATION SITE PAIN (soreness on the injection site) outcome was unknown and VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE INDURATION (hardness on the injection site) and VACCINATION SITE PRURITUS (itching real bad injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment or concomitant medications reported.; Sender'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.
Generalized itching, high blood pressure 20 minutes after dose - taken to ER, given benedryl and monitored BP - discharged home 3 hours later, take benedryl as needed and see primary physician for BP spike
Small amount of hives, took an allergy relief and symptoms went away. Hives came back, took Benadryl and symptoms went away. Repeat process for 4-5 days. On 5th night, increase in amount of hives, all over back and face, took Benadryl and eventually went away. Went to walk-in, provider recommended Claritin and Pepcid daily. I've taken those for three days now with the occasional Benadryl and haven't noticed any hives. Hives varied in size and location. Ultimately in all different areas of my body at one point of another. I have pictures if needed.
Patient is a 75 y.o. female patient of PRIVATE, MD presented headache, nausea and chills and was found to be COVID-positive.   She has a background history of breast ca and hyperlipidemia.   Nausea/Chills/Headache Diarrhea She is afebrile at present, still with nausea. Symptoms likely due to COVID. She was on chemotherapy. Antiemetics and fluid hydration. No further nausea vomiting or diarrhea.   Covid-19 Virus Infection Date of onset of symptoms: 11/1/22 Symptoms present on admission: nausea, headache Date of covid positive test: 11/2/22 Vaccination status: vaccinated Imaging: CXR-atelectasis vs. Early infiltrate Oxygen requirements on admission: none Current oxygen requirements:none Medical therapy: Remdesivir Consultants following: ID  Anticipated special isolation end date: 11/12/22    Remains on room air.  No cough.  Afebrile.  No need for further medications.   Hypokalemia Corrected. Monitor other electrolytes and correct deficits.   Breast cancer Neutropenia History of hormone receptor positive metastatic breast carcinoma, on therapy with palbociclib and letrozole. Neutropenia likely chemotherapy-induced. Appreciate oncology input. Hold off on growth factor for now. Hold palbociclib at discharge, continue Letrozole.  Repeat CBC next week before starting palbociclib.  Dr. to follow.
Patient had hematoma at injection site, reported rash was told to follow up with PCP.
Fever of 102 degrees 8/24/18. Entire body was sore. It is now 8/25 and I am waiting to see if my fever returns. I have been taking Tylenol to keep the fever down.
10/15/06 arm tender 2 hours after shot, 10/16/06 red with whelps 2 inch diameters, tender and aching to touch. Pt states 10/17/06 slight redness, but resolving. No whelps at this time.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On an unknown dates, the patients were inadvertently vaccinated with PNEUMOVAX 23 (lot#, expiration date, dose and route were not reported), that had been improperly stored. No adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
Left deltoid was swollen 2 x's its original size. DTaP shot site was bruised 1/2 way up the injection site. It was hot to the touch and pt was in a little pain
I was also tested positive/pneumonia; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number and expiration date not provided, via an unspecified route of administration on 25Jan2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. In 2021, a week later, the patient was tested positive and was there in the hospital for 5 days, the patient had pneumonia in the hospital. Still recovering on 15Feb2021 supposedly the date of patient's 2nd shot and cannot get it and cannot go down due to the storm. The outcome of the event was unknown.   Information on lot/batch number has been requested.
ACTHIB was administered using a sterile water diluent instead of the provided diluent with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received from health professional on 24-Aug-2022.  This case involves a 15-month-old female patient who was administered vaccine HIB (PRP/T) VACCINE [ACT-HIB] using a sterile water diluent instead of the provided diluent with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Pneumococcal Vaccine CONJ 13V (CRM197) (Prevnar 13) for Immunization.  On 23-Aug-2022, the patient received 4th dose of suspect ACT-HIB vaccine at dose 0.5ml once (lot UJ594AA) via intramuscular route in the left thigh for prophylactic vaccination administered using a sterile water diluent instead of the provided diluent with no reported adverse event (product preparation error) same day latency.  Action taken: Not applicable.  At time of reporting, the outcome was Unknown.     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 the 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.
Swelling, redness, heat to touch, spreading from injection site down to elbow, covered entire upper arm.
Swelling and redness at the site of injection. Bruise after two days. No chills, no fever noted. Mom reported giving BENADRYL. Mom called office to report adverse event. She declined visit stating that she is comfortable with home care.
Rash on Lt arm approx size 3"X 5" with itching that started on 02/08/2021 and continues to be present and uncomfortable. Due to have 2nd injection on 03/01/2021. Recommendations state probably need to receive 2nd dose in Rt. arm, but can't due to having lymph node removed due to breast cancer.
Patient reports itching in the area of his left arm. He is moved to the back area with a paramedic for evaluation and several maps of outbreaks started to appear in the back area, abdominal area, red and swollen arms, vitals are taken.