chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tingling in both hands; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in both hands) and PAIN IN EXTREMITY (arm pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058F2A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Blood pressure high. Concomitant products included METOPROLOL and HYDROCHLOROTHIAZIDE for Blood pressure high.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On an unknown date, the patient experienced PARAESTHESIA (tingling in both hands). At the time of the report, PARAESTHESIA (tingling in both hands) and PAIN IN EXTREMITY (arm pain) 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.   patient took cholesterol pill as concomitant medication. patient took Tylenol for the arm pain as treatment medication.
Rash; pain at the injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at the injection site), CHILLS (Chills) and RASH (Rash) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at the injection site) and CHILLS (Chills). On 02-Mar-2021, the patient experienced RASH (Rash). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (pain at the injection site), CHILLS (Chills) and RASH (Rash) had resolved.            Action taken with m-RNA1273 was considered to be not applicable.   Reporter did not allow further contact
4 hours after receiving vaccination had a temp of 101 and dizziness. On 10/19 arm became hot to touch, achy at injection site, fever.
malignancy/cancerous/three tumors/lump in my left breast; Pain and soreness in left arm; swelling of the arm; biopsy breast abnormal; three lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of BREAST CANCER (malignancy/cancerous/three tumors/lump in my left breast) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-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 BREAST CANCER (malignancy/cancerous/three tumors/lump in my left breast) (seriousness criterion medically significant), PAIN IN EXTREMITY (Pain and soreness in left arm), PERIPHERAL SWELLING (swelling of the arm), BIOPSY BREAST ABNORMAL (biopsy breast abnormal) and LYMPHADENOPATHY (three lymph nodes). At the time of the report, BREAST CANCER (malignancy/cancerous/three tumors/lump in my left breast) had not resolved and PAIN IN EXTREMITY (Pain and soreness in left arm), PERIPHERAL SWELLING (swelling of the arm), BIOPSY BREAST ABNORMAL (biopsy breast abnormal) and LYMPHADENOPATHY (three lymph nodes) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Mammogram: abnormal (abnormal) three tumors and three lymph nodes. On 11-Mar-2021, Ultrasound scan: cancerous (abnormal) cancerous. On 24-Mar-2021, Biopsy breast: confirmed malignancy (abnormal) confirmed malignancy.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant product use was not provided by the reporter.  Treatment information includes on 09 Apr2021 started chemotherapy for breast cancer NOS, continuing since then.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.   This case was linked to MOD-2021-276971 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Expired vaccine was admistered to patient, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves an unknown age male patient who received an expired dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (batch number not reported, expiry date: 22-Mar-2019) via unknown route and unknown site of administration, 02-Oct-2019  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error due to expired vaccine used.  At the time of reporting the patient had 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 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.  Information on the batch number was requested.  List of documents held by sender: none.
When I got COVID-19, I woke up with a cough, mucous coming out of my nose, left side of my throat felt inflamed. I took a home COVID-19 test  and it was negative but I felt awful so I went to the urgent care and they did possibly a rapid test because I had the positive results in about 15 minutes. At the urgent care center, they gave PAXLOVID and prednisone because I do have asthma.
I did not have a reaction to the vaccine. I began not feeling well on 06/04/2023 and took a COVID-19 test. It was negative. I have an upper respiratory infection. I was not given an antibiotic because they believe it's bacterial. I was given a prescription for a steroid and an inhaler.
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, VITAMINS NOS (DAILY VITAMINS) and UBIDECARENONE (COQ 10) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (Vertigo). On 25-Mar-2021, VERTIGO (Vertigo) had resolved.            The patient reported the event after the second vaccine was not as bad as the first but she did get an aura for which she laid on the floor to prevent injury. No other treatment information was provided.   This case was linked to MOD-2021-235399 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Follow up received on 24-Jun-2021 and contain significant information. Added patient details, updated concomitant drug information. Updated outcome of the event vertigo.
flu; This is a spontaneous report from a Pfizer-sponsored program Covax US support.  A Non contactable consumer reported for a female patient (reporter's sister).  A female patient of unspecified age received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on an unspecified route as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, after the vaccination, the patient got sick with the flu. The events assessed as non-serious. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
the second shot my arm was sore for 3 days, mild symptoms of flu. 10 days later I was having shortness of breath.
This spontaneous report as received from a Registered Nurse refers to unspecified patients of unknown age and gender. Medical history and concurrent conditions were not provided. Since 02-FEB-2015, unspecified patients were vaccinated with a dose of improperly stored M-M-R II (dose, route, lot number and expiry date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
approx 30 mins p/vax pt recvd vax & back to clinic saying pt has been shaking, eyes rolled back; lethargic; t103.8; exam showed no other signs of illness; ER MD told mom pt had sz post vax;
inflammation of her lymph nodes near the neck at the injection site; inflammation of her lymph nodes near the neck at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 23Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 19Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: LYMPHADENITIS (non-serious), VACCINATION SITE INFLAMMATION (non-serious), outcome "unknown" and all described as "inflammation of her lymph nodes near the neck at the injection site". Therapeutic measures were taken as a result of lymphadenitis, vaccination site inflammation.  Additional information: Treatment: She took anti Inflammatory medication.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient felt like passing out, got very white in the face, eyes rolled back into head. Then he was ok.
Breakthrough case admission after three vaccines Moderna 2/4/21 Lot# NOT NOTED;  Moderna 3/4/21 LOT # NOT NOTED;  MOderna 11/2/21 Lot# 039F21A
Ear Ringing/Tinnitus, increased blood pressure, dizziness and vertigo, pounding heartbeat, blurry vision, irritability and crying, feelings of being overwhelmed, muscle cramping, headaches, body aches
9 days after she got the results of testing positive; This is a spontaneous report from a Pfizer A 63-year-old female patient received the first dose of the BNT162B2 (Pfizer covid vaccine, lot number: unknown) via an unspecified route of administration injected in left arm in the muscle as a single dose on 23Mar2021 09:00, for Covid-19 immunization. The patient's medical history included cholesterol and concomitant medications included an unspecified cholesterol medication. On 31Mar2021 approximately 19:00, she was tested positive for covid. Her second dose was scheduled on 13Apr2021. There was no history of previous immunization and was not administered any additional vaccines on same date or prior vaccinations (within 4 weeks) of the Pfizer Suspect.  She did not went to any emergency room or physician's office visit, neither undergone any relevant test. She did not know if she was completely recovered.  She was ok, but it had only been 9 days after she got the results of testing positive. The outcome of the event was unknown.   Information on the lot/batch number has been requested.
Started with cough on the 13th the next day cough persisted the morning of 15th I knew I was not well, spoke with physician assistant who instructed to take covid home test, once diagnosed I was given paxlovid within 3-5 days I started to feel better
Itching and progressively got worse. IM site looks good. No swelling, redness noted. Faint rash noted on right arm and back and right plank.
He got his vaccine today, he has light headedness, thirsty, feeling not up to par.  He can function, but is concerned about going to work tonight.   Nothing else is bothering him.
Approximately 30 minutes following vaccine administration patient complained of feeling that her heart was racing and that she was lightheaded.  Pulse 90 and BP 110/78.   Sat and had some water and a snack.  No further complaints.
7/13/04 developed fever- max 103 & rash on trunk with some on arms, legs and face- itchy, symptoms lasted 3-4 days. Parent phoned doctor no visit required.
1st shot: hard knot in arm, sight redness. 2nd shot: bigger, hard knot, redness and swelling, about 1/2 area of bicep. 3rd shot: knot about size of silver dollar. Redness and swelling covered whole upper arm, very hot to the touch.
Child was brought in for an office visit six days after immunizations were given for localized rash of R arm around injection(s) site. Was treated for diagnosis of cellulitis. Was advised ibuprofen, benadryl, and ice as treatment. Note this office has reported another localized reaction to same Dtap lot number.
Heart racing; Tinnitus; Dizziness; Cantaloupe sized injection site; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart racing), TINNITUS (Tinnitus), DIZZINESS (Dizziness) and VACCINATION SITE SWELLING (Cantaloupe sized injection site) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 041C21A) for COVID-19 vaccination.     The patient's past medical history included Cancer.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021, the patient experienced PALPITATIONS (Heart racing), TINNITUS (Tinnitus), DIZZINESS (Dizziness) and VACCINATION SITE SWELLING (Cantaloupe sized injection site). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 10-May-2021, PALPITATIONS (Heart racing) and VACCINATION SITE SWELLING (Cantaloupe sized injection site) had resolved. At the time of the report, TINNITUS (Tinnitus) and DIZZINESS (Dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to MOD-2021-137496 (Patient Link).
Pt complained of mild fever post vax. Pt stated that fever continued for 2-4 hours.
Began breaking out 10/30/02. Some are just pink bumps and some are blisters. Using Zovirax and Aveeno baths. Did not see physician. No fever reported.
I came into the facility to administer COVID vaccines for residents/staff.  The registration form for patient said it was her first dose and was signed by her POA. I administered the vaccine and discovered as I was logging the information into Impactsiis that the resident had received the complete series of PFIZER. Her first dose was on 01/11/21 and her second was on 02/01/2021. I administered MODERNA on 04/28/21. I spoke to the administrator to make him aware. I contacted the facility on 4/29 and they said the resident had lack of energy, wouldn't eat and her blood pressure was running 135/48.  The physician had them monitoring the blood pressure every 30 minutes.
headache, chills, vomiting began about 10 hours after the second dose.  these symptoms resolved within 24 hours.  I then had a persistent headache.  On 2/14/21 I felt a rush sensation up the back of my neck and head, with warmth and tingling in my neck, head and ears.  I had red flushing of my ears and pain near the base of my head.  The tingling in head, neck and ear would come and go throughout the day. Posterior headache got worse and I had episodes of feeling off balance/dizzy lasting minutes then resolving.   Over the next few weeks I developed tingling in my face, most persistent on  the right side of my face near my outer mouth and chin.  Tingling on my face occurs almost daily and still persists since February.  I also have tingling/warm sensation on the tops of my feet, shins and arms.  My R arm often feels like it's "falling asleep".
Systemic: Chest Tightness / Heaviness / Pain-Mild, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Hypertension-Mild, Systemic: Visual Changes/Disturbances-Mild
One week after shot was given, itchy red rash on left shoulder where vaccination was administered. Rash warm to the touch. Went to urgent care, was given MEDROL oral tablet therapy pack for six days and took BENADRYL.
Received first vaccine without any symptoms.  Received second vaccine on 2/16 and on 2/19 she started with hives and itching on her buttocks, migrating to thighs, hands, face.  Resolved with Benadryl
The first Pfizer Covid Vaccine helped her breathing/Pfizer Covid Vaccine booster dose and the same thing happened, her breathing was fine again, better.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Lot number: EN6202), in right arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 320308D) at the age of 72 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COPD" (ongoing), notes: Onset date unknown other than years ago. She has been on inhalers for years and years for COPD.; "Vitamin D deficiency" (unspecified if ongoing), notes: She thinks she had a vitamin D deficiency but that was before all of this. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 2, SINGLE. Batch/Lot No. Unknown, Expiry: Unknown, Upper Arm.), administration date: 26Mar2021, when the patient was 72-year-old, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "The first Pfizer Covid Vaccine helped her breathing/Pfizer Covid Vaccine booster dose and the same thing happened, her breathing was fine again, better.".  Additional Information: There was product complaint to report (product is not suspect product) with Description of Product Complaint as patient has been on inhalers for years and years for COPD. After first Pfizer Covid Vaccine noticed whenever went to take Advair inhaler in the morning would start to cough. So patient stopped taking Advair Inhaler. Patient was not using Advair inhaler for like 6 months after getting first Pfizer Covid Vaccine, After about 6 months started having a bit of a problem breathing again. When booster came out she went and got the Pfizer Covid Vaccine booster dose and the same thing happened, her breathing was fine again, better. She tried to get off inhalers numerous times on her own prior to this and never could. Would only last maybe 2-3 days at the most and then have to take the inhaler again. Reporter did not provide any additional inhaler product names regarding been on inhalers for years and years; tried to get off inhalers; only provided Advair inhaler. Description of complaint of the product Advair inhaler, Manufacturer name Glasko Smith Kline with NDC no. 0173-0717-20 for lot K35H with Expiry as 20Aug2022.  Follow-up (07Apr2022): This is a spontaneous follow-up report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included the lot number for the booster dose was 320308D.   No follow-up attempts are needed. No further information is expected.
Sore arm; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired). At the time of the report, PAIN IN EXTREMITY (Sore arm) and FATIGUE (Felt tired) outcome was unknown.            No Concomitant medications were provided No Treatment information provided   This case was linked to MOD-2021-009215 (Patient Link).
States left arm deltoid area was painful immediately after injection left arm at injection area became red and warm to touch immediately. On 11/3/04 approximately 1pm red rash developed on face and chest and then spread to abdomen back legs and arms. On 11/4 experienced extreme itching all over body. On 11/4 injection area left arm swollen red and warm to touch. ON 11/4 took Benedryl 50 mg at 11Am. By 5pm itching and rash redness improved. On 11/5 rash gone. Left deltoid area still red and warm to touch.
Inflammation; Swollen joints in hands andfingers, and left jaw; Painful joints in hands and fingers, and left jaw (feels something like arthritis); This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205) via an unspecified route of administration in the left arm, on 12Mar2021 at 15:00 (at the age of 69-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications included amlodipine besilate (MANUFACTURER UNKNOWN), sotalol hydrochloride (MANUFACTURER UNKNOWN) and escitalopram (MANUFACTURER UNKNOWN) all since an unknown date for unknown indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. On an unknown date in Mar2021 at 12:00 (as reported), the patient had experienced swollen, painful joints in hands, fingers, and left jaw. The patient felt something like arthritis and inflammation. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatment were not taken for the reported events. The clinical outcome of the events swollen joints, inflammation and arthritic-like pain were not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Transient global amnesia lasting from around 2pm on January 7th until the next morning when patient awoke.
It was reported that an 18 year old female pt received Menomune on 7/15/03. Three days later, the pt developed a fever of 102 deg, chills, body aches and headache. The pt took antipyretics. She was evaluated by her physician on 7/19/03. The pt's recovery status was not reported.