chrisvoncsefalvay/vaers-outcomes huggingface dataset:
developed shingles two days after 2nd dose of vaccine; This is a spontaneous report from a non-contactable consumer, the patient. A 38-years-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration on 23Mar2021(at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration on 03Mar2021(at the age of 38-years-old) 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. On 25Mar2021, two days after second dose of vaccine, the patient developed shingles. The event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of shingles and included treatment with antiviral medication. The clinical outcome of the event shingles was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
terribly sensitive leg; trouble walking; ankle was terribly painful; leg on injection side, especially ankle was terribly painful; severe hematoma/hematoma ran from her bicep to her hand; nearly turned back; very painful; severe reaction; barely could move her arm/barely stand to move; arm swelled; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (severe hematoma/hematoma ran from her bicep to her hand), ADVERSE DRUG REACTION (severe reaction), MOBILITY DECREASED (barely could move her arm/barely stand to move), PERIPHERAL SWELLING (arm swelled) and SKIN DISCOLOURATION (nearly turned back) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0152M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included CLOPIDOGREL BISULFATE (PLAVIX) and ACETYLSALICYLIC ACID (ASPRIN) for an unknown indication.  On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 05-Feb-2021, the patient experienced ADVERSE DRUG REACTION (severe reaction), MOBILITY DECREASED (barely could move her arm/barely stand to move), PERIPHERAL SWELLING (arm swelled) and PAIN (very painful).   On 06-Feb-2021, the patient experienced HAEMATOMA (severe hematoma/hematoma ran from her bicep to her hand) and SKIN DISCOLOURATION (nearly turned back).   On 08-Feb-2021, the patient experienced PAIN IN EXTREMITY (terribly sensitive leg), GAIT DISTURBANCE (trouble walking), ARTHRALGIA (ankle was terribly painful) and AXILLARY PAIN (leg on injection side, especially ankle was terribly painful).   At the time of the report, HAEMATOMA (severe hematoma/hematoma ran from her bicep to her hand), ADVERSE DRUG REACTION (severe reaction), MOBILITY DECREASED (barely could move her arm/barely stand to move), PERIPHERAL SWELLING (arm swelled), SKIN DISCOLOURATION (nearly turned back), PAIN (very painful), PAIN IN EXTREMITY (terribly sensitive leg), GAIT DISTURBANCE (trouble walking), ARTHRALGIA (ankle was terribly painful) and AXILLARY PAIN (leg on injection side, especially ankle was terribly painful) outcome was unknown. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Patient's treatment plan included that at the ER patient's arm was wrapped with gauze and put her arm in a sling. Patient has been advised to apply pressure and limit movement.
child recv vax & grandparent devel shingles;child's cousin devel shingles 6-7wk post the child vax;
T 103.0, Altered level of consciousness, General weakness, Nursing observations; Resident noted with altered mental status. Resident was unable to verbally respond to commands.  MD notified ordered given to be transferred to hospital for future evaluation.
This is a spontaneous report from a contactable consumer or other non-HCP (patient). A patient, of unspecified age and gender, received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 24, 2021, single dose, for COVID-19 immunization. The patient's medical and concomitant medications not reported. The patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 3, 2021, single dose, for COVID-19 immunization. On Feb 25, 2021, patient experienced dizziness, headache, heavy eyes and blurry vision. On an unspecified date in Feb 2021, patient experienced chills and fatigue. The chills lasted for 5 to 6 hours. On Feb 26, 2021, patient still felt fatigued but returning to normal. The outcome of chills and fatigue: recovering; of the other events: unknown. No follow-up attempts possible. Information about batch/lot number cannot been obtained.
patient came in for shingrix shot but the pharmacist gave pfizer bivalent booster by mistake.
Information has been received from a case in litigation via a case report concerning a female patient who on 14-OCT-1997 and 02-DEC-1997 was vaccinated with RECOMBIVAX HB (Lot number not reported). On an unspecified date, 24 hours post vaccination, the patient developed and continued to suffer from an ill defined neurologic disorder characterized by myalgias, and arthritis and consistent with fibromyalgia. No further information is available.
Pt reports fever, headache and rash within 24 hrs. of receiving vaccine. Pt also reports extreme tiredness & weakness. Pt reports going to the emergency room 1 week later, and then saw her doctor. Reports sickness lasted 1 mth. No treatment was ever provided/needed.
Headache started a couple hours after injection and lasted 48 hours. Joint pain started approximately 6 hours following injection and lasted 48 hours.
On Monday Dec. 14, 2009 received H1N1 vaccine IM @ 2:05pm. Within 15-20 minutes of receiving vaccine felt nauseated and dizzy. Within about another 15 to 20 minutes reported blurry vision. ER physician suggested to tx symptoms with Benadryl.
Was in menopause for two years and had a six day heavy period after taking first does of Pfizer vaccine.  A vaginal sonogram was performed and a biopsy occurred both results were negative.    Sonogram technician stated several women were coming in for the same reason. I have not had another period since.
Vertigo; I feel like I'm going to lose my balance; don't dare to bend over from the waist; feeling fatigue; This spontaneous case was reported by a physician and describes the occurrence of VERTIGO (Vertigo), BALANCE DISORDER (I feel like I'm going to lose my balance), DYSKINESIA (don't dare to bend over from the waist) and FATIGUE (feeling fatigue) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Lot# 031L20A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (Vertigo), BALANCE DISORDER (I feel like I'm going to lose my balance), DYSKINESIA (don't dare to bend over from the waist) and FATIGUE (feeling fatigue). At the time of the report, VERTIGO (Vertigo), BALANCE DISORDER (I feel like I'm going to lose my balance), DYSKINESIA (don't dare to bend over from the waist) and FATIGUE (feeling fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication was provided.
Patient was administered an expired dose of PFIZER BIONTECH COVID 19 vaccination on 6/3/2021 at 0838. Vaccination was outside of the recommended time allowed following first vial puncture.  Syringe containing Pfizer vaccination was approximately 12-16 hours out of the recommended 6 hour allotted time frame for administering.  Writer contacted manufacturer, Pfizer regarding above error. Please use reference if further information is needed regarding call. No recommendation  was given by manufacturer as this particular situation has not been studied in clinical studies to da,Client from Pfizer medical information notes they are unable to provide medical guidance regarding patients, it is up to the discretion of primary care provider to determine when patient can safely another COVID 19 vaccination.  Patient was notified of error and  is not currently experiencing any adverse side effects.  Patient will contact clinic with any further concerns or development of symptoms listed in the Pfizer-Biotech Covid 19 emergency use authorization literature.
The day after the vaccine I experienced headache, body aches, chills and weakness. Please note that I did not have a severe case of Covid, very mild. The reaction to the vaccine was much worse than the actual virus for me. I felt better the next day.
Approximately 15 min after injection, patient reported itching and redness at injection site. Diphenhydramine 12.5mg/5mL oral soln given. patient then reported her head felt funny. HR 85 BP 167/102. O2 sat 99% RR 18. After 15 min another Diphenhydramine 12.5mg/5mL given. BP 163/102 HR 82 O2 sat 98%. Pt denied ever having shortness of breath or difficulty breathing. EMS evaluated patient, patient declined transport, was taken home. At home BP was 153/94 HR 73. Pt reported shorter reaction after receiving TDAP in 2015, but has had several influenza vaccines since then without any problems.
Mom called clinic 3OCT91 & gave hx of inc fever 28SEP91 & 29SEP91 p/fever broke on 29SEP91 pt had sz & was taken to hosp ER & transferred to another hosp;
arm was sore for about 4 days, low grade fever at about 36 hours, some swelling and rash around the injection site, headache about 48 hours after injection.  No symptoms after the soreness in arm subsided.  Took ibuprophen for fever and pain, did not need or seek medical attention.
This case was reported by a healthcare professional and described the occurrence of unable to get out of bed in a 46-year-old female subject who was vaccinated with Engerix B for prophylaxis. On 19 September 2006, 13 December 2005 and 31 January 2005 the subject received 3rd dose, 2nd dose and 1st dose of Engerix B at 10 mcg (pediatric dose), two doses given in the right arm for an adult dose total of 20mcg. For the 1st dose, two separate lot numbers of 10 mcg Engerix B were administered to the subject. The numbers were AHBVA06200 with expiration of 14 November 2005 and ENG5506A2 with expiration of 05 February 2005. Following completion of the three dose series of Engerix B, on 30 November 2006, a titer was drawn that revealed that the subject was non-responsive to Engerix B, therefore, an additional series of Engerix B was started. Following a 4th dose of Engerix B given on 19 December 2006, the subject complained of hardly being able to get out of bed and she was experiencing shoulder pain, back pain and chest pain. She was unable to move. The subject's physician diagnosed her with bursitis in her right shoulder. The 5th dose of Engerix B was administered in the subject's left shoulder on 07 May 2007. The next morning, on 08 May 2007, the subject reported that she was barely able to sleep the prior evening, her arm hurt and she was experiencing chest pain. The subject was taken to the emergency department and she was admitted to the hospital. The subject was worked up for heart issues and the physician reported that she may have experienced a possible adverse event to the Engerix B. The subject remained hospitalized at the time of reporting. The healthcare professional considered the events were disabling and clinically significant (or requiring intervention). At the time of reporting the events were unresolved.
The initial reaction was severe headache and body aches, nausea, fatigue, sore throat, earaches, fever, chills.   The 6-24 hours after the vaccine was the worst, seeing some improvement today at almost 48 hours.  It seems my sinus infection from a week ago has returned since I have those reoccurring symptoms of head pressure, ear aches, sore throat. I do still have some body aches and fatigue.
Rapid loss of smell and some taste on the morning of Sep 3, 2021.  This followed two or three days of a mild headache and scratchy throat.  I had no fever.
second on 15Apr2021 and third dose of the vaccine on 18Aug2021; third dose of the vaccine on 18Aug2021; gave patient their 3rd vaccine dose from the expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave patient their 3rd vaccine dose from the expired vial), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second on 15Apr2021 and third dose of the vaccine on 18Aug2021) and EXTRA DOSE ADMINISTERED (third dose of the vaccine on 18Aug2021) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included PREDNISONE for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave patient their 3rd vaccine dose from the expired vial) and EXTRA DOSE ADMINISTERED (third dose of the vaccine on 18Aug2021). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second on 15Apr2021 and third dose of the vaccine on 18Aug2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave patient their 3rd vaccine dose from the expired vial) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second on 15Apr2021 and third dose of the vaccine on 18Aug2021) and EXTRA DOSE ADMINISTERED (third dose of the vaccine on 18Aug2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information were not provided by the reporter.  Patient received 3rd dose of vaccine on 18th Aug 2021 at 02:50 PM (Batch#: 088D21A) in the left arm. Vial has been dispose as of now confirmed by the pharmacist. Patient received second dose of vaccine on 15th April 2021 (Batch#: 036B21A)   This case was linked to MOD-2021-291158 (Patient Link).
3/14/07 - At 1pm developed generalized rash. 3/15/07 At 6:00am, T.100.4 at 7:30 increase 101.5. Seen in primary care office. Fever and diffuse erythema multiforme - sent to E.D04/17/07-records received from facility for DOS 3/21/07-DX:Fever, erythema multiforme, urinary tract infection. Temp in ER 100.7 (R) repeat 101.Seen in ER nine days prior with same complaints. Treated with antibiotics. Diarrhea developed. Urticarial looking rash 24 hours after vaccine.
fever of 102.1; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102.1) in a 95-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PYREXIA (fever of 102.1). At the time of the report, PYREXIA (fever of 102.1) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Body temperature: 102.1 degree Celsius High.         No relevant concomitant medications were reported. Treatment details included Not provided.
LITTLE BIT SLEEPY; FATIGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced little bit sleepy, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from little bit sleepy, and the outcome of fatigue was not reported. This report was non-serious.
Patient was vaccinated on 5 April 2008.  11 April pt had severe headache, tenderness at the site; 12 April pt looked at site- "huge red spot all over my arm- was getting bigger and bigger- around the back of my arm". Pt states there was also a lot of pus at the site. Other symptoms: temp 102 degrees; stiff neck, difficulty sleeping.  Pt spoke to his family physician who told him to come to the clinic where he was vaccinated because his doctor did not have a shot record for the patient.  Pt presented to this clinic on 15 April and was sent to the Medical Center for treatment.  The immunization tech at the Clinic called and informed me that he felt that it was not an adverse rxn to vaccine but an infection due to improper care of the site and that he was not going to do a VAERS report.  Member was given antibiotics for deltoid cellulitis.
raw, red moist sore @ vax site; 3mo persistent intermittently raw, red & moist, raised; would devel gray, thin membrane, which would be removed by pt's application of alcohol
Developed tingling, numbness, pain and strange pulsating in outer extremities (including calf, foot, forearm, midarm and hand) on same side of body as where the dose of Moderna booster was administered (right). These symptoms developed on 01/06/2022 (2 days after the dose was administered).
Pt reported onset of tinglingness and numbness in her Left arm and left side of her face 1 hour post injection which was worsening in severity as time passed. No did not report any pain/swelling or difficulty breathing.
Pt. reported headache, nausea and vomiting, fever of 101.8 degrees F.
SADDLE PULMONARY EMBOLISM 4/28/2023 ACUTE PULMONARY EMBOLISM ACUTE PULMONARY EMBOLISM 4/29/2023 ACUTE PULMONARY EMBOLISM ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/29/2023 ACUTE PULMONARY EMBOLISM
About 10-15 days after receiving the second dose of the vaccine,  I experienced  symptoms similar to those of a panic attack. light-headedness, a fluttery sensation in the chest (heart area) and temblor in the hands.
Swelling, redness, itchy and painful if touched. Slight headache. 15mm x 15mm erythema with 4mm lump.
Reconstituted with unapproved diluent; Reconstituted with unapproved diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 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 are as follows: The age at vaccination was not reported. Nurse reported that the patient (no data available when asked) received Shingrix vaccination but it was reconstituted with other diluent than the supplied, they used an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No other information were provided. The reporter consented to follow-up.
Information has been received concerning a white female with no known allergies who on 20-JUL-2001 was vaccinated SC with Varivax (639128/0567L). Suspect vaccination that day included a SC dose of MMR (lot # 639618/0736L). There was no illness at the time of vaccination. On 07-JUN-2006 the patient developed a rash. Medical attention was not sought and no laboratory diagnostic tests were performed. The patient's outcome was recovered on 07-JUN-2006. It was reported that the patient's sister (WAES# 0606USA04662) had a similar experience after vaccination with Varivax. Additional information is not expected.
This spontaneous report was received from a registered nurse concerning an unspecified patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided.  On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # N017698; expiration date: 09-JUN-2019) or (lot # N017701; expiration date: 09-JUN-2019) for prophylaxis, which had a temperature excursion of 6F to 14F for 2 hours 12 minutes on an unknown date. Previous temperature excursions included the same previous temperature for 2 hours 48 minutes and 15F to 46F for 1 hour 59 minutes. The digital data logger was involved in recording the temperature excursion. The vaccine was reconstituted with properly stored dose of sterile diluent (MERCK). No adverse effect was reported. No product quality complaint was involved. This is one of the several reports from the same source. Sender's Comments: US-009507513-1801USA005992.
The thing that I noticed on my smart watch my O2 levels have been dipping below 90%. I had a blood test liver enzyme elevated; red blood cell count was elevated; alanine transaminase level was 95 UL normal range is 10 -61; My total Cholesterol high 255. I'm working on improving my sleep quality.
gave expired dose of ACT-HIB to a patient with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from physician via Medical Information (Reference number- 00708771) and transmitted to Sanofi on 03-Aug-2021.  This case involved 3-month-old male patient gave expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (expired product administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for prophylactic vaccination.  On 30-Jul-2021, the patient received first dose of suspect HIB (PRP/T) VACCINE (lot: UU357AAB and expiry date: 26-Jul-2021) (Frequency = once) (Strength = standard) (Form: solution for injection) via intramuscular route in the left thigh for prophylactic vaccination (expired product administered)  It was reported that, "doctor is calling to see what they need to do and reported the event".   This was an actual medication error due to expired vaccine used (latency: same day)  At the time of reporting, no 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 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.
Achiness, chills and fatigue for 2 days.  Better for 1 day, worked and went for a run, then woke up in middle of night going into 4th day post vaccine with severe aches.   Got Covid tested on day 4, came back negative on day 5.  I am now on day 11 post vaccine and am still having aches in my hip joints.  I?m unsure if it?s related to the vaccine but I haven?t been able to run (I am a regular runner) without pain.  I did not have any pain from running prior to the vaccine.