chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain Barre syndrome; Rash; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4339008-00 (AbbVie).  A 71 year-old male patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) at the age of 71 years as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (hospitalization, medically significant) with onset Dec2021, outcome "not recovered", described as "Guillain Barre syndrome"; RASH (non-serious), outcome "recovered", described as "Rash". The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of guillain-barre syndrome. Clinical course: It was reported that patient's wife stated that he stopped Humira in 2021 because he kept getting rashes. In dec2021, he got guillain Barre syndrome and he was in a nursing home on a ventilator. It was unknown if patient was enrolled in a COVID-19 Vaccine trial.  The reporter's assessment of the causal relationship of events with suspect product Humira (adalimumab) for Guillain Barre syndrome was no reasonable possibility and for rash was reasonable possibility.  The reporter's assessment of the causal relationship of events with suspect product (Bnt162b2) was possible.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on limited information in the case , a possible causal association between   the reported  events and the suspect drug BNT162B2 cannot be excluded. 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
Student received nasal flu vaccine. She was in the 'shack (watch)' area and her face became flush & red hives & welts on chest/trunk area of body. Pinna of both ears, red & hot. 945 AM BENADRYL 12.5 mg PO given. 950 0.3mg Epi (1:1000) given (L) deltoid. Pulse 120, O2 95%, BP 125/100, T- 101. Transported to ER via ambulance. Parents to meet at ER.
Breakthrough case admission after 3 vaccines; Pfizer 1/15/21 Lot# EL1283; ; Pfizer 2/10/21 LOt# EL9267; Pfizer 8/19/21 lot# FC3184.
After 1st dose - stomach began churning constantly within a week, scalp and side of face tingling occasionally,  After 2nd dose - stomach churning increased, scalp and face tingling more pronounced within 1st week,  occasional nausea and tingling in pinky fingers and lack of appetite 2nd week, occasional tingling in pinky toe and sides of ankles as well as more nausea and chest discomfort during 3rd week when resting (1st ER visit),  pronounced tingling in fingers and feet as well as farther up legs 4th week when experienced difficulty walking after one night where entire legs had formication and calf cramping (2nd ER visit).     Symptoms then dissipated on their own approx 8 weeks after first appearing
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), on 28Sep2021 as dose 3 (booster), single (Lot number: EN6207) at the age of 78 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 had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (unspecified date) Negative, notes: tested negative after completing Paxlovid; (23Jul2022) positive, notes: He presents today and has tested positive for COVID. Therapeutic measures were taken as a result of covid-19 which include Paxlovid from 09Jul2022 to 14Jul2022.  Clinical course: The patient had no known allergies. The patient did not receive other medication in 2weeks before COVID 19 Treatment.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a possible contributory role of the suspect drug to all  the reported events Drug ineffective, COVID-19  cannot be completely excluded based on temporal association and known drug safety profile
Pt presented to clinic 5-7-12 painful swelling under (L) arm. She was given Tdap on Wed, had painful arm at site of injection by Sat. Then swollen mass (L) axillary region.
My whole right upper chest is in pain since Saturday (Pfizer 1st vax right upper arm on Fri).., The pain started in my arm and moved  to My upper chest... Now, Sunday, my whole right side chest hurts (outside muscles, not inside pain, i touch the muscles and it hurts to the touch),
Systemic: Seizure-Mild, Additional Details: Patient got the vaccine and was waiting in the waiting area for observation for 15 minutes after shot her friend came and adressed that patient is having seizures. Patient has history of seizures upon asking her last seizure was couple weeks ago and had 2 cluster seizure at that time. Her max cluster seizure she has had is 5. Patient said she was very anxious about vaccine and she had worked up on the axiety all day long and that caused seizure. Patient said she does not take any med for seizure
Hives and red marks, breathing problems and wheezing with cough.  Fever.
Patient complained of pain to throat when swallowing at 9:56, after receiving vaccination. Pain unresolved with water. Vital signs were stable, no swelling or erythema, uvula midline. At 10:31, dexamethasone 4 mg was given by mouth. At 11:05, patient verbalized symptom improvement.
Severe vomiting, severe diarrhea, fever, body aches, nausea, no appetite, abdominal pain, headaches, dizziness, chills, diaphoresis
10 to 12 cm area of erythema, tenderness, induration, and warmth right deltoid when came to clinic 3/17 due to reaction, states onset symptoms immediately after vaccine.  No systemic symptoms
(Arm pain for about 3-5 days that lessened as time progressed, Slight headache, vomited Sunday,  and what I consider migraine fog symptoms ( others seem to be calling this fatigue),  vertigo, tinnitus (like shuffling cards but I didn?t realize what it was.  After 2nd shot  continued vertigo, 1 fall down the stairs (tore PCL in my knee), constant tinnitus now like ?eeeee?
Shortness of Breath; Fever; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of Breath) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced DYSPNOEA (Shortness of Breath) and PYREXIA (Fever). On 19-Apr-2021, DYSPNOEA (Shortness of Breath) and PYREXIA (Fever) had resolved.        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.   Treatment information was not reported by the reportere.  Concomitant product use was not provided by the reporter.   This case was linked to MOD21-089504, US-MODERNATX, INC.-MOD-2021-123376 (E2B Linked Report).; Sender's Comments:  MOD21-089504:crosslinked US-MODERNATX, INC.-MOD-2021-123376:Husband case
Swollen of left eye as well as face and arms and it is itching; Swollen of left eye as well as face and arms and it is itching; Swollen of left eye as well as face and arms and it is itching; Swollen of left eye as well as face and arms and it is itching; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 6-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 at 18:00 as dose 3 (orange cap; booster), single (Lot number: GK1657) at the age of 6 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE; Lot No: FK9895, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM), administration date: 02Mar2022, when the patient was 5-year-old, for Covid-19 immunization; BNT162b2 (DOSE 1, SINGLE; Lot No: FL0007, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM), administration date: 09Feb2022, when the patient was 5-year-old, for Covid-19 immunization. The following information was reported: EYE SWELLING (non-serious), SWELLING FACE (non-serious), PERIPHERAL SWELLING (non-serious), PRURITUS (non-serious) all with onset 24Nov2022 at 17:00, outcome "not recovered" and all described as "Swollen of left eye as well as face and arms and it is itching". The events "swollen of left eye as well as face and arms and it is itching" required physician office visit. Therapeutic measures were not taken as a result of eye swelling, swelling face, peripheral swelling, pruritus.  Additional information: Patient had not been received any other vaccine within four weeks and any other medications. Patient not experienced covid prior vaccination nor post vaccination.
This spontaneous report has been received from a nurse practitioner refers to an 11 months old patient. The patient was vaccinated with initial doses of both VARIVAX (Merck) and M-M-R II on 05-JUL-2009 at another (unspecified) provider's office. Nurse Practitioner reports that the child received the second dose of each vaccine on 20-July-2012. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
This spontaneous report as received from a physician and from a support services director via two company representatives refers to a patient of an unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 21-OCT-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 10PK-0.5 ml SD-PFS LLok w Tip (lot# L022262, expiry date 05-NOV-2016; dose and route of administration were not reported). There were no concomitant therapies reported. The dose of the vaccine was exposed to temperature excursion (date unspecified): lasting for 48 hours, with the lowest recorded temperature of 39 degrees Fahrenheit (-1.66 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
diarrhea; dry heaving; nausea; vomiting; This case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 30-year-old male patient who received Flu unspecified (Flu vaccine) for prophylaxis.   In August 2019, the patient received Flu vaccine. On an unknown date, less than a week after receiving Flu vaccine, the patient experienced diarrhea, dry heaves, nausea and vomiting. On an unknown date, the outcome of the diarrhea, dry heaves, nausea and vomiting were recovering/resolving.   It was unknown if the reporter considered the diarrhea, dry heaves, nausea and vomiting to be related to Flu vaccine.  Additional details were provided as follows: The patient experienced frequent diarrhea, dry heaving, nausea, and vomiting. The patient consented to follow up. Emergency room visit was required. The patient did not provide any additional information. The patient did not have healthcare professional contact information at the time of reporting.
COUGH; DIFFICULTY SLEEPING/STRUGGLING TO SLEEP; LOSS OF ENERGY/ESPECIALLY NO ENERGY; SHIVERING; FATIGUE/FEELS  VERY TIRED; COLD SYMPTOMS; HEART RATE INCREASED/FAST HEART BEAT; VERTIGO; BRAIN FOG; CHEST PAIN; This spontaneous report received from a patient concerned a 43 year old male. The patient's height, and weight were not reported. The patient's past medical history included pneumonia, and concurrent conditions included covid-19, and other pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029, expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 (vaccinated at left deltoid) for prophylactic vaccination. No concomitant medications were reported. On 19-MAR-2021, the subject experienced cold symptoms. On 19-MAR-2021, the subject experienced heart rate increased/fast heart beat. On 19-MAR-2021, the subject experienced vertigo. On 19-MAR-2021, the subject experienced brain fog. On 19-MAR-2021, the subject experienced chest pain. On 19-MAR-2021, the subject experienced difficulty sleeping/struggling to sleep. On 19-MAR-2021, the subject experienced loss of energy/especially no energy. On 19-MAR-2021, the subject experienced shivering. On 19-MAR-2021, the subject experienced fatigue/feels very tired. On 20-MAR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold symptoms, and shivering on 20-MAR-2021, and was recovering from heart rate increased/fast heart beat, fatigue/feels very tired, vertigo, brain fog, chest pain, loss of energy/especially no energy, cough, and difficulty sleeping/struggling to sleep. This report was non-serious.
Rash on torso appeared2 days after vaccine (10-28-20) :  - Across entire torso, no fever - Raised, crusty, not painful , not itchy
Developed mild myocarditis, milf pericarditis, and costochondritis, took steroids
(L) neck, shoulder pain, (L) thumb numbness, atrophy of (L) supraspinatus, infraspinatus muscle.
Patient called to report possible Shingles vaccine reaction.  I spoke with patient on 18 Nov. Pt states she received Shingles vaccine on 13 November at pharmacy where nursing was providing Shingles vaccines to TRICARE Beneficiaries on 12, 13, and 14 Nov.  Pt states she noticed swelling "size of a goose egg, with rash in circle and itching around vaccine site on L arm on Saturday the 15th. She stated, she spoke with local pharmacist who recommended she take Benadryl, which she is currently taking. Pt denied swelling in her arm or fingers of left arm, no fever, no behavior changes, no face or throat swelling, no difficulty breathing, no dizziness or weakness.  She states the swelling has gone down.  I recommended to patient to draw a circle around swelling and if swelling exceeds circle or she has a fever or does not feel well to visit her PCM.
Pt recv vax on 2/10/98; on same day pt exp unconsolable crying, fever (103), difficulty sleeping; tx=Tylenol; pt imp 2/12/98
Headache, Fever, FATIGUE, PAIN/SWELLING INJ SITE Narrative:
moderna vaccine November  Pt developed severe itching and pain at injections site immediately following injection  Pt noted edema and tissue growth with central recurrent bleeding at the injection site after injection this progressed until seen on 1/10/22 at which time it was evident that the pt had need for tissue resection and biopsy.  biopsy positive for proliferation of squamous cells consistent with SCC
Suspected COVID-19 virus infection  Acute URI  Chief Complaint Patient presents with ? Covid-19 Screening     Fatigue, cough, nasal congestion sx starting yesterday.      Patient is a 22 y.o. male    2 days   Fatigue, headache, nasal congestion, sore throat, cough, diarrhea Taking tylenol XS    COVID - 1ST DOSE VACCINATED 05/15/21 COVID 2ND DOSE vaccinated 06//19/2021
she had the prickly feeling like when her nerves were regenerating; feeling draining from my right arm from the site of the shot downward to my finger tips/ I lost more and more feeling; numbness in my peripheral nerves/have not fully regained the feeling in my palm and fingers; trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue; could not get my arm to move and steer the car properly; weakness; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number : ER2613) via an unspecified route of administration, administered on the right arm on 21Mar2021 10:30 at a single dose for COVID-19 immunization. Medical history included GBS (when I was 20 years old), Type 2 diabetes mellitus and high blood pressure related to type 2. Concomitant medications included rosuvastatin and metoprolol succinate. The patient previously took paracetamol (TYLENOL) and experienced allergies (anything with Tylenol). In less than 5 hours after the vaccine (21Mar2021 03:30 PM), patient started to feel the feeling draining from her right arm from the site of the shot downward to her finger tips. As each hour passed, she lost more and more feeling. She had complete numbness in her peripheral nerves for over 48 hours and have not fully regained the feeling in her palm and fingers. She had trouble working due to the issues with typing and issues playing piano. Basic things like holding a cup and driving were an issue and nearly caused an accident yesterday b/c she could not get her arm to move and steer the car properly. It has considerable weakness as well. The feeling between her right and left arm were distinctly different and it's really frightening. She was scared she won't get the feeling back in her right arm fully. From my elbow down was still a significant issue. Last 01Apr2021 she did have one incident where she had the prickly feeling like when her nerves were regenerating. The events resulted to a doctor or other healthcare professional office/clinic visit, Disability or permanent damage. No treatment was received for the events. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Outcome of the events was not recovered.
Patients states that she experienced muscle soreness that lasted for 5-6 days and developed a circular rash on her left arm. She states that the sore area of her arm felt warm to the touch and she was able to control her pain with OTC Tylenol. She states that the discomfort wasn't significant enough to require medical treatment.
expired dose of the Moderna COVID-19 vaccine was administered; expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (expired vaccine was stored in refrigerator (vaccine expired on 01-Apr-2022 and stored in refrigerator on 05-Apr-2022)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  The reporter reported that they received Moderna COVID-19 vaccine vials with a manufacturing date of 01-Dec-2021 and an expiration date of 01-Apr-2022 (Lot: 026L21B). The reporter used Moderna's online expiration tool to confirm the expiration date.  The reporter reported that unknowingly, expired doses of the Moderna COVID-19 vaccine were administered to 20 patients from lot 026L21B. The administration occurred from 06-Apr-2022 to 09-Apr-2022. The vials were initially stored in the refrigerator was on 05-Apr-2022 and the vials did not undergo any temperature excursions.  The patient did not report any adverse reactions.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-537580, MOD-2022-538614, MOD-2022-538672, MOD-2022-538673, MOD-2022-538676, MOD-2022-538677, MOD-2022-538678, MOD-2022-538681, MOD-2022-538682, MOD-2022-538688, MOD-2022-538689, MOD-2022-538691, MOD-2022-538692, MOD-2022-538693, MOD-2022-538696, MOD-2022-538698, MOD-2022-538701, MOD-2022-538702, MOD-2022-538688, MOD-2022-538614, MOD-2022-538698, MOD-2022-538689, MOD-2022-538672, MOD-2022-538676, MOD-2022-538692 (Patient Link).
Mild headache, pressure over forehead/eyes. Feeling feverish. Temp 97.6 oral. Generalized aches and pains. Slight dizziness. The next day, all symptoms gone. Injection site/sore arm for 3 days.
Body aches and joint aches; Fatigue; Severe chills; Nausea; Backache; Shivering; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization , Unknown manufacturer), for Covid-19 Immunization.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "Body aches and joint aches"; FATIGUE (non-serious), outcome "unknown"; CHILLS (non-serious), outcome "unknown", described as "Severe chills"; NAUSEA (non-serious), outcome "unknown"; BACK PAIN (non-serious), outcome "unknown", described as "Backache"; CHILLS (non-serious), outcome "unknown", described as "Shivering".  Additional information: Concern, reporter stated, she was just calling to ask a question. We got our 3rd COVID-19 Booster shot on Monday afternoon late and my friend (consumer) like 2 days later started having the normal things like just like body aches, fatigue while in the next day severe chills, nausea, joint aches and then yesterday she felt pretty fine last night and then today I mean severe chills, nausea and her backache. Should we go to the Doctor or are these normal things? I mean is it like severe chills and shivering.  When paraphrased the concern, reporter stated, "Yes, the 3rd one she had done Moderna Booster (COVID-19 Vaccine) and the first time she had for the Pfizer (COVID-19 Vaccine) at (name withheld)Pharmacy."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.