chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt has itching, swelling, erythema about 3in. long/wide. Advice to apply ice, give BENADRYL 25ml. Discuss sign and symptom of cellulitis advice to return if sign and symptom get worse. Mother verbalize understanding.
Approximately 7-10 days post vax, pt developed rash on left side of body.
Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Mild, Systemic: Headache-Mild
stroke; Left side stroke which affected his speech, and right side; This is a spontaneous report from a contactable consumer. A 69-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number En6199 and expiration date unknown), via an unspecified route of administration in the left arm on 07Mar2021 at 11:00 at a single dose for COVID-19 immunization. Medical history included myasthenia gravis, rheumatoid arthritis, and high blood pressure. Concomitant medications included pyridostigmine (PYRIDOSTIGMINE), metoprolol (METOPROLOL), tamsulosin (TAMSULOSIN) and amlodipine (AMLODIPINE). The patient had known allergies with aspirin [acetylsalicylic acid]. The patient had no other vaccine in four weeks. The patient had a left side stroke which affected his speech and right side, on Tuesday morning 48 hours after taking the vaccine (on 09Mar2021 at 05:00). The event resulted in emergency room/department or urgent care, hospitalization, disability or permanent damage. It was also reported that treatment was administered for the events and the patient was still in the hospital. The patient had no COVID-19 prior vaccination and has tested post vaccination (09Mar2021), with a pending result. The patient was recovering from the events at the time of the report.
felt like he was getting the flu; sick to his stomach; soreness on his arm; dizzy; body hurt all over; chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he was getting the flu), ABDOMINAL DISCOMFORT (sick to his stomach), PAIN IN EXTREMITY (soreness on his arm), DIZZINESS (dizzy) and PAIN (body hurt all over) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical information was provided by the reporter.     On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like he was getting the flu), ABDOMINAL DISCOMFORT (sick to his stomach), PAIN IN EXTREMITY (soreness on his arm), DIZZINESS (dizzy), PAIN (body hurt all over), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and DIMENHYDRINATE (DRAMAMINE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like he was getting the flu), ABDOMINAL DISCOMFORT (sick to his stomach), PAIN IN EXTREMITY (soreness on his arm), DIZZINESS (dizzy), PAIN (body hurt all over), CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.
8-year old receives quadracel with no reported adverse event; Initial information received on 02-Nov-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 8 years old and unknown gender patient who was administered with DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the 8 year old patient who received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number and expiry: unknown) (product administered to patient of inappropriate age) (dose, formulation and strength: unknown) via unknown route in unknown administration site for prophylaxis vaccination.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS AND IPV VACCINE (QUADRACEL) was not applicable.  At time of reporting, the outcome was Unknown for the event 8-year old receives quadracel 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 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.
-REDNESS AND SWELLING ON INSIDE APPROXIMATELY 2 -3 INCHES ABOVE ELBOW. -EXTREME FATIGUE. -REPORED 24 HOURS AFTER VACCINATION.
Last 3 days projectile vomiting and diarrhea, pt uncomfortable while eating and cranky. Dx at appointment on 1-9-2018: Feeding issues, switch to formula.
Patient fainted after administration for approximately 10 minutes. Was laid in supine position until she felt well enough to sit upright.
ADMINISTER EXTRA DOSE FROM THE VIAL; This spontaneous report received from a pharmacist concerned multiple patients. 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 not reported, batch number: 1802070 expiry: 25/MAY/2021) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 11-MAR-2021, the subject experienced administer extra dose from the vial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administer extra dose from the vial was not reported. This report was non-serious.
Patient reported increased swelling and pain in her right knee within days after receiving her 2nd Covid 19 vaccine. States her pain was at an 8-10 level making it hard for her to do much of anything or get around.
Pronounced weakness in both hands, especially pinky and ring fingers, difficulty holding and manipulating objects, lethargy, unusual joint pain.
Patient reports light headed, dizzy, upset stomach, cyanotic for approx 30 mins. Difficulty returning to baseline, ambulance was called for further evaluation and monitoring. Unknown whether patient was transferred from the site for further care.
SWELLING; ITCHING; RASH; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced swelling, itching, and rash. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the rash, swelling and itching was not reported. This report was non-serious.
7/29/2020  pt went to the ER with fever and rash on face, torso, and legs
GBS deficits of hypersensitivity; numbness; hand tremor; could not walk; Guillian-Barre Syndrome; This serious case was reported by a consumer and described the occurrence of guillain barre syndrome in a 64-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. In JUN-2023, less than a week after receiving Shingles vaccine, the patient experienced guillain barre syndrome (Verbatim: Guillian-Barre Syndrome) (serious criteria hospitalization and GSK medically significant) and unable to walk (Verbatim: could not walk) (serious criteria hospitalization). On an unknown date, the patient experienced hypersensitivity (Verbatim: GBS deficits of hypersensitivity) (serious criteria hospitalization), numbness (Verbatim: numbness) (serious criteria hospitalization) and tremor of hands (Verbatim: hand tremor) (serious criteria hospitalization).  The outcome of the guillain barre syndrome, hypersensitivity, numbness, tremor of hands and unable to walk were not reported.   It was unknown if the reporter considered the guillain barre syndrome, hypersensitivity, numbness, tremor of hands and unable to walk to be related to Shingles vaccine.     It was unknown if the company considered the guillain barre syndrome, hypersensitivity, numbness, tremor of hands and unable to walk to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-SEP-2023 The patient reported approximately one week or less following first Shingles vaccine she acquired Guillain-Barre Syndrome and was not able to walk and spent 3 weeks in hospital and received the treatment to prevent further neurological damage to nerves and underwent PT and OT (occupational therapy and physical therapy) to relearn to walk and function independently. During the reporting she was in outpatient PT and was working hard in recovery. It was uncertain if her acquired Guillain-Barre Syndrome deficits of hypersensitivity, numbness and hand tremor would improve. Prior to acquiring Guillain-Barre Syndrome there were no infections or other vaccines which contributed to Guillain-Barre Syndrome.
Breakthrough case admission after 5 vaccines  Moderna 2/9/21 Lot# 015M20A;  MOderna 3/9/21 Lot# 032M20A;  Moderna 10/28/21 Lot# 076C2A;  Moderna 4/21/22 Lot# 057M21A;  Pfizer 9/12/22 Lot# GJ2524
Got vaccine on Wed, fatigue started on Sat at first then headaches off and on and by Sun had muscle aches that got progressively worse.  Mon I worked for 4 hours at desk job and by the end my ribs and back hurt so bad I caught myself holding my breath when breathing. Went home and laid sown the rest of day. Tues slept till 4:30 in the afternoon and then laid down rest of day. Slept till 11am on Wed and rested rest of the day. Headache and muscle pain not as bad. Called doctors office Wed and doctor wasn't in. Nurse will talk to him tomorrow and call if he advises anything mofre then what she had said which was rest. drink plenty of fluids and take tylenol.  She advised to sign up for v-safe to VAERS.
PATIENT RETURNED TO PHARMACY CONCERNED WITH REDNESS, WARMTH, SORENESS, AND SWELLING AT THE INJECTION SITE AND SURROUNDING AREA WHICH SHE HAS NEVER PREVIOUSLY EXPERIENCED AFTER A VACCINATION.
Covid 19/ home test positive; Covid 19/ home test positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 21Mar2021 as dose 1, single (Lot number: ER2613), on 11Apr2021 as dose 2, single (Lot number: EW0161) and on 08Sep2021 as dose 3 (booster), single (Lot number: FC3183) at the age of 51 years for covid-19 immunisation. The patient's relevant medical history included: "Lymphoma" (unspecified if ongoing). The patient had no known allergies. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Covid 19/ home test positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Covid-19 Treatment-Paxlovid; (21Apr2022) Positive, notes: I began feeling quite congested and took a home test showing me positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: By 13Apr I was feeling better. By 18Apr I felt most symptoms were gone. On 21Apr I began feeling quite congested and took a home test showing me positive. Contacted my GP. 22Apr symptoms lessoned. Since have had a snotty, runny nose and a very sporadic dry.
Injection pain; headache; tiredness/feeling wornout; chills; body aches; chest tightness; This is a spontaneous report from a contactable consumer.  A 48-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3249), via an unspecified route of administration in the left arm on 09Jan2021 at 09:00 at 48-years-old at a single dose for COVID-19 immunization. Medical history included Sulfonamide allergy, Factor V Leiden mutation, diabetes; all from an unknown date and unknown if ongoing.  Concomitant medications included acetylsalicylic acid (BABY ASPIRIN), colecalciferol (VITAMIN D [COLECALCIFEROL]), lisinopril (MANUFACTURER UNKNOWN), vitamins nos (MULTIVITAMIN); all taken for an unspecified indication from an unspecified date to an unspecified date.  The patient experienced the following events and outcomes: injection pain on 09Jan2021 20:00 with outcome of recovering , headache on 09Jan2021 20:00 with outcome of recovering, tiredness/feeling wornout on 09Jan2021 20:00 with outcome of unknown, chills on 09Jan2021 20:00 with outcome of recovering, body aches on 09Jan2021 20:00 with outcome of recovering, chest tightness on 09Jan2021 20:00 with outcome of recovering. The patient did not receive other vaccines in four weeks; there was no treatment for the adverse events; there was no prior COVID vaccination; there was no post vaccination COVID test.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021015284 same patient, different event and vaccine
Pt received Pfizer vaccines on 12/28/21 and 01/16/2021. Pt tested positive for COVID outpatient on 10/29/21. Pt presented to the ED on 11/08/21 with complaints of worsening SOB, fever, cough, and  congestion. Pt did not require supplemental oxygen and was discharged home on 11/09
Body aches; Soreness on the chest; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), CHEST PAIN (Soreness on the chest) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Body aches), CHEST PAIN (Soreness on the chest) and CHILLS (Chills). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN (Body aches), CHEST PAIN (Soreness on the chest) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: NNI
in the summer of 1990 pt began aching in all joints & muscles w/inc stiffness; ER 1992 (AUG or SEP) did blood work & referred to rheumatologist in OCT-MD dx'd rheumatoid arthritis; daily pain-Ibuprofen, Naprosyn; cont stiffness & some swell
Rash / Rash on the face and body/ rash on arm neck; Rash is pimply; This case was reported by a nurse via sales rep and described the occurrence of rash in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA12AZ, expiry date 28th February 2021) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (dTpa vaccine) (batch number C5609AA, expiry date 4th April 2021) for prophylaxis, MENACTRA (batch number U5869AB, expiry date 26th January 2021) for prophylaxis and GARDASIL (batch number RO24271, expiry date 8th May 2021) for prophylaxis.   On 5th August 2019, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On an unknown date, the patient received dTpa vaccine, the 1st dose of MENACTRA and the 1st dose of GARDASIL. In August 2019, less than a week after receiving Bexsero and dTpa vaccine, the patient experienced rash and papular rash. On an unknown date, the outcome of the rash and papular rash were unknown.   It was unknown if the reporter considered the rash and papular rash to be related to Bexsero and dTpa vaccine.  Additional case details were reported as follows: The vaccine lot number and expiry date was unknown. The nurse reported to a field representative that a patient reported a rash within 2 days of Bexsero administration.  The patient developed a rash after having Bexsero, not itchy, on the face and body. The rash was pimply in appearance on face, arms, and neck. No other information was available. It was unknown how long the rashes lasted and if they were treated because reporter only called in to report the adverse event. The reporter consented to follow up. This is 1 of the 4 linked cases reported by the same reporter.
Left arm sore  at day 10, arm itching, large red hive, itching down arm.
headache, severe sinus headaches, sinus pressure, shortness of breath, sense of water in ears, loss of hearing, off balance, vertigo, emotional/crying jags, feeling of being poisoned,
Patient's arm (shoulder to elbow) was red, swollen, hot to touch, burning, skin peeled.
Within 3 days of vax, had swelling, redness & itching around site of injection & it felt warm to touch. Redness was size of lemon toward medial part of arm. These sxs lasted approx 2 wks. Still itches & has dry, flaky skin at site now.
Stroke; A spontaneous report was received from a consumer concerning a 48-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced stroke (cerebrovascular accident).   The patient's medical history was not provided by the reporter.  Concomitant product use was not reported.  On 30 Dec 2020, approximately 11 days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot #: 037K20A) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.  The reporter stated that on 10 Jan 2021, the onset of symptoms of stroke began.  The patient reports that he was discharged from the hospital on 20 Jan 2021 and was later discharged from patient rehabilitation on 26 Jan 2021.  Treatment for the event included apixaban, acetylsalicyclic acid, and atorvastatin as advised by patient's HCP (health care provider).  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event, stroke, was unknown.; Reporter's Comments: This case concerns a 48 year old male who experienced stroke 11 days after the vaccine was administered. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Since I had the second shot of the Moderna vaccine I had fever for 4-5 days, headaches,  ear pain, high blood pressure and my heart beat much higher than normal.  I went to my doctor office but I didn't get better. I follow up after 3 weeks because I wasn't feeling well and my doctor send me to ER. They did some tests but they send me home that day.  I had to go back to my primary doctor becuase until today's day I still with high blood pressure and my hart rate is higher than normal is. I still feeling effects and it has been more than a month. Very frustrating as no one can tell me what is wrong with me.
Treated for Pneumonia, has not yet fully recovered.  Patient also has low back pain, very lethargic, collapsed while walking, legs painful, tingling in hands and feet, incontinence, headache, unsteady while walking and standing
No adverse event; Drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 25-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 immunisation: PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with PFIZER BIONTECH COVID-19 VACCINE, PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE. Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 29-Sep-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (Drug exposure during pregnancy).    Treatment medications were not reported. Company Comment: This is a spontaneous case concerning a 25-year-old female patient with no reported medical history, who received the fourth dose of mRNA-1273.815 (Spikevax 2023-2024) during pregnancy (39 weeks pregnant). Maternal exposure during pregnancy was considered in this case and no adverse events were reported. No further clinical information was available for medical review. The benefit-risk relationship of mRNA-1273.815 (Spikevax 2023-2024) is not affected by this report.