chrisvoncsefalvay/vaers-outcomes huggingface dataset:
angioedema @ inj site on lt deltoid;erythema/edema involving 2/3 of deltoid in band-like distribution;
Woke up morning after injection with shoulder pain which increased in intensity with evolving decrease in ROM over the course of the following months.  I saw Dr. on March 18 and was diagnosed with L glenohumeral joint injury and had a L shoulder x-ray.  Pain continued to increase upon movement = severe L shoulder joint pain with radiating nerve pain down outside of left arm to elbow and left-hand numbness and weakness.  Waking up several times in the night in excruciating pain from having moved joint in my sleep.  Per Dr.  I went to PT who diagnosed it as frozen shoulder.  I started on a prednisone taper on April 2 and subsequent physical therapy.   I am continuing with pain and decrease ROM although improved after steroid course.  I am also continuing with physical therapy.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance for the long term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. In 2016, the patient was treated at a medical center for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Fever up to 102.4 for 4 days.  Given Motrin for comfort.  Small red dots on torso and back and neck that appeared on 4/4/2011.
approx 24 hrs following vax pt devel severe h/a; h/a more intense then other migraine; pt hospitalized for 2 days; p/2 days in hosp pt was fine;
Rigors that lasted about 10 minutes at around 45 mins to 1 hour post vaccine. Elevated heart rate.
Received Tdap vaccine on Thur, 9/29/2016.  Noticed tenderness, redness and a knot by 1 day later.  Got worse through weekend, but then began to improve and now is starting to look and feel better.  Denies fever, loss of movement in L arm.  Has not tried any remedies.
L aRm warmth, tingling, heaviness Tx: vitAls, monitored Received 2ND dose 1/20/21 - No adveRse reaction
Pt recvd vax 20JUN91 exp crying unconsolable x 4hr; legs from knees down & arms red & hot to touch; Seen in ER by MD given med;
6 month old was given PENTACEL that expired 22JUN2021 with no reported adverse event; Initial information received on 15-Apr-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 6 months old and unknown gender patient was given pentacel that expired 22jun2021 with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a unknown dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious 6 month old was given pentacel that expired 22jun2021 with no reported adverse event (expired product administered) (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event 6 month old was given pentacel that expired 22jun2021 with no reported 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 guidelines. 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.
dose of polio vaccine was given that was 1 week expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from Nurse  This case involves a 44-year-old female patient who vaccinated with a 0.5 mL (total, once) dose of IPV (VERO) [IPOL] that was later noted to have 1 week expired (lot R1F801M, expiry date 20-Sep-2021) via intramuscular route in the left deltoid on 05-Oct-2021 for prophylactic vaccination (expired product administered).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  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.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Additional Details: pt complained of feeling hot, then lost consciousness while seated for approx 10 sec, pt was given cold cloths and ice pack, given water to sip, and monitored for 30 min. when pt felt recovered, she left, and was followed up by phone call approx 1 hr later, experiencing no further adverse effects
patient stating that he started having runny nose and sneezing on 04/13/21 after receiving vaccine on 04/07/21.  Patient is advised to contact his primary care provider and take OTC antihistamine.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Physician).  A 48-year-old male patient received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Lot number: 3013087) at the age of 48 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "hypercholesterolemia" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Ag test positivity 11 days after initial positive test; Positive, notes: Ag test positivity 11 days after initial positive test. Therapeutic measures were taken as a result of covid-19.  Clinical course: The consumer started Paxlovid on 03May2022 for Treatment of COVID-19 till 07May2022. Adverse event: Recrudescence of symptoms and Ag test positivity 11 days after initial positive test and 6 days after completion of paxlovid therapy. Adverse event start date: 14May2022, If patient recovered: Recovering, If treatment ae: No (as reported). No other medication in 2 weeks.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information available and close temporal association, a possible contributory role of the suspect Product cannot be excluded for the reported events . The case will be reassessed once new information is available.
Edema in legs  Shortness of breath  Low O2 saturation via pulse oximeter
They reported significant body aches.; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; 15 persons received Pfizer vaccine from vials that has been reconstituted with 1.3 mL instead of 1.8 mL.; This is a spontaneous report from contactable physician. A patient of unspecified age and gender received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications was not reported. It was reported that 15 persons received Pfizer vaccine from vials that had been reconstituted with 1.3 mL instead of 1.8 mL which led to Overdose and Inappropriate dilution of medication and reported significant body aches. The clinical outcome for the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  Follow-up attempts have been completed and no further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021188834 Same reporter/drug/event, different patient.
C/O redness to left deltoid after Tdap vaccine. Slight redness noted and warm to touch.
COVID 19 Treatment; COVID 19 Treatment; vaccine brand other=Moderna/vaccine administration date=24Oct2021,; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01Mar2021 as dose 1, single (Lot number: EN6202), in left arm and on 22Mar2021 as dose 2, single (Lot number: ER8730) at the age of 37 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Oct2021 as dose 3 (booster), single (Lot number: 011F21A), in left arm and on 07Sep2022 as dose 4 (booster), single (Lot number: AS7144B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: MUCINEX, start date: 01Jan2023, stop date: 05Jan2023. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=Moderna/vaccine administration date=24Oct2021,". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: testing every day and tests were very faintly positive,; positive, notes: but have progressively gotten darker again the last two days (days 10-11); positive, notes: but have progressively gotten darker again the last two days (days 10-11). Therapeutic measures were taken as a result of vaccination failure, covid-19, PAXLOVID as treatment.
Information was received on 15-AUG-2017 from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient was inoculated with a dose of ZOSTAVAX vaccine on or about 26-OCT-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-OCT-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by a weakened immune system, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Same side effects as after the 2nd dose, however, in the evening on 1/8/22 I started to experience extreme itchiness and hives all over my face, neck and chest.  I took Benadryl which provided some relief but I still feel quite itchy.
15 seconds post administration of vaccine, c/o burning at site and then headache. She then fainted. She then had tonic/clonic movement lasting five seconds of upper extremity. She became conscious in less than one minute of incident. 0.3cc of 1:1000 adrenalin given SQ above vaccine injection site. Pt slowly awoke when given. BP and HR stable throughout incident. A hive was noted at site of vaccine. Stayed in clinic 1 hr and gone and felt fine. Uft with mom.
headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Reporter did not allow further contact
5.5 cm x 4.5 cm warm, very tender, edematous and erythematous area on left deltoid.   Pt having body aches - bad enough shes been in tears, site is very painful, chest pain/heaviness/tightness (had EKG done), cough, chills/fever, HA, diarrhea, abnormal period - has had vag bleeding when period just ended 6 days ago.
Pt left to car after being in office 10 min, returned w/complaints of slurred speech, dizziness, (R) side of body numb. Hard to move (R) side of body, (R) side mouth droopy. Traveling from head to toe not all at same time.
Pt has red, warm round (3 in X 4 in) spot on arm, where vaccine given.  No other symptoms reported by patient or patient's mom.
got flu like symptoms; muscle aches; fever; sweating; shivering; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms, muscle pain, fever, sweating and shivering. On an unknown date, the outcome of the influenza-like symptoms, muscle pain, fever, sweating and shivering were unknown.   It was unknown if the reporter considered the influenza-like symptoms, muscle pain, fever, sweating and shivering to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced influenza-like symptoms, muscle pain, fever, sweating and shivering after receiving 1st dose of Shingrix. The patient asked was it likely would get the same reaction with the 2nd shot of Shingrix. No other information was provided.
Administered vaccine after 12 hrs of 1st puncture of vial; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DISPENSING ERROR (Administered vaccine after 12 hrs of 1st puncture of vial) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No medical history was reported.     On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT DISPENSING ERROR (Administered vaccine after 12 hrs of 1st puncture of vial). On 16-Jun-2021, PRODUCT DISPENSING ERROR (Administered vaccine after 12 hrs of 1st puncture of vial) had 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 Concomitant  information was  provided. No Treatment information was  provided.
Difficulty Walking; unable to get out of bed; Weakness; This case was reported by a consumer and described the occurrence of walking difficulty in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th December 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th December 2020, less than a day after receiving Shingrix, the patient experienced weakness. On 11th December 2020, the patient experienced walking difficulty and mobility decreased. On an unknown date, the outcome of the walking difficulty, mobility decreased and weakness were not recovered/not resolved.   It was unknown if the reporter considered the walking difficulty, mobility decreased and weakness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the daughter of the patient. The patient received Shingrix in left deltoid and on same night the patient complained of weakness. The patient was unable to get out of bed next morning due to severe weakness. The patient needed assistance getting out of bed to make it to the bathroom and had difficulty walking.
pt recv vax & 3mo later pt devel full blown chicken pox;MD reported 3 patients;
Vaccine administered per order. Upon documentation, syringe noticed to have an expired expiration date (6/18/2021). The syringe was mistakenly located in a box with a valid  lot/expiration date.
Headache, Fever, Pain at the tope of nose, Chills and weakness Narrative:  Received 2nd dose on 1/20/21. Awoke at 0200 on 1/21/21 with  fever/chills, headache, and pain at top of nose. Temp ranged from 101.7-103 on  1/21/21 and 2/22/21. Noted arm swelling/red/warmth all along deltoid to the elbow lasted through 1/25/21. Missed work x 2 days. No known prior COVID infection.   Other Relevant History:
shingles; Information has been received from a lawyer regarding a case in litigation. This case refers to a 74 year old female patient (pt). The pt's pertinent medical history, concurrent conditions and concomitant medications were not provided.  In November 2016, the pt was administered zoster vaccine live (ZOSTAVAX) by unknown route, for prophylaxis. As a result of this administration, in January 2017, the pt suffered shingles, including any and all of its sequelae. Additionally, pt suffered severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages, and suffered serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. Pt required and/or would required more health care and services and did incur medical, health, incidental and related expenses. Also, she would, in the future, be required to obtain further medical and/or hospital care, attention and services. At reporting time, pt was not recovered from herpes zoster and it was considered to be related to Zoster Vaccine Live (ZOSTAVAX). Herpes zoster was considered to be a disabling event.
Still sick; Itchy throat; Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds; Eyes are crying/watery eyes; Itchy eyes; Sinus pressure; Eyes hurt; Teeth hurt; Ear hurt; severe allergic reaction; Felt like head was exploding; Swollen arm; Very tired/kind of tired; Pain in my arm/sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), ILLNESS (Still sick) and PARANASAL SINUS DISCOMFORT (Sinus pressure) in a 56-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.     The patient's past medical history included COVID-19. Concurrent medical conditions included Sinusitis (Sinus allergies).    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PAIN IN EXTREMITY (Pain in my arm/sore arm) and FATIGUE (Very tired/kind of tired). On 02-Oct-2021, the patient experienced PERIPHERAL SWELLING (Swollen arm). On 04-Oct-2021, the patient experienced RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), PARANASAL SINUS DISCOMFORT (Sinus pressure), EYE PAIN (Eyes hurt), TOOTHACHE (Teeth hurt), EAR PAIN (Ear hurt), HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (Felt like head was exploding). On 06-Oct-2021, the patient experienced THROAT IRRITATION (Itchy throat). On 08-Oct-2021, the patient experienced ILLNESS (Still sick). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at a dose of 10 mg. On 02-Oct-2021, PAIN IN EXTREMITY (Pain in my arm/sore arm) and FATIGUE (Very tired/kind of tired) had resolved. On 04-Oct-2021, PERIPHERAL SWELLING (Swollen arm) had resolved. On 06-Oct-2021, THROAT IRRITATION (Itchy throat) had resolved. At the time of the report, RHINORRHEA (Runny nose / My nose, I mean literally it's coming out of my face.  I have to blow my nose every 10 seconds), LACRIMATION INCREASED (Eyes are crying/watery eyes), EYE PRURITUS (Itchy eyes), ILLNESS (Still sick), PARANASAL SINUS DISCOMFORT (Sinus pressure), EYE PAIN (Eyes hurt), TOOTHACHE (Teeth hurt), EAR PAIN (Ear hurt), HYPERSENSITIVITY (severe allergic reaction) and HEADACHE (Felt like head was exploding) 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 relevant concomitant medications were reported.
Initial report received from a healthcare professional (veterinarian) on 17 October 2012. The male patient (date of birth: 31 December 1943), whose medical history and concomitant medications were not reported, had received FLUZONE HD (batch number, route and site of administration were not reported) and a few weeks ago at 3:00 M on an unspecified date. On an unspecified date, after receiving FLUZONE HD vaccine, by 5:30 PM the patient started began to "fee funny", his eyes felt dry and irritated and began to feel unwell. Approximately one hour later the patient developed joint pain, muscle aches, felt cold and had to chills. The patient did not take his temperature and was not certain if he had a fever. The patient did not require medical treatment or intervention for his symptoms and was not seen by physician. The laboratory investigations were not reported. By 4:30 AM the following day, the outcome was recovered. Documents held by sender: none.