chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 01/26/2022 I had a severe sore throat. Shortly thereafter I had total body soreness and fatigue. I also had chills and fever of 101. These symptoms lasted maybe a good 3 days. I started to feel better after 3-4 days I did start to feel better. I did treat with OTC Nyquil and Mucinex.
Patient began feeling dizzy about 2 weeks post vaccine. About a week later headache started. She has been fatigued continues to feel dizzy every day several times a day, her headache is daily all day long, she has episodes of tachycardia, feels forgetful and has trouble concentrating. She has been diagnosed with autonomic dysfunction.
3.5 x 2.5 inch erythematous area at injection site that is tender, warm to touch, swollen.    Pt treating with otc steroid cream, ice.    currently monitoring area.
Cryptogenic Stroke-permanant partial loss of vision in right eye, incomplete motor control on left side.
Information has been received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent (manufacturer unknown). On 01-SEP-2017, the patients were vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # M044720, expiration date: 07-MAY-2018, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. Administered vaccine experienced the temperature excursion of -14 Celsius degree to -10 Celsius degree (-14.2 Celsius degree) for 6 hours. There was no previous temperature excursion. Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. All telephone attempts on 10-OCT-2017 to obtain follow up information have been unsuccessful. Follow up information has been received from another reporter concerning a 4 year old patient. On 14-SEP-2017, the patient vaccinated with improperly stored PROQUAD (dose, frequency and route were unknown, lot # N013863, expiration date: 31-OCT-2018) for prophylaxis. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1709USA002186: US-009507513-1709USA002098.
24 hrs after shot: severe nausea for 1 day; 2 day - neckack and headack; 3rd day just small amount of ackes
This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 67-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 13th July 2020). On 19th April 2018 02:40, the patient received the 1st dose of SHINGRIX .5 ml. On 19th April 2018 02:40, immediately after receiving SHINGRIX, the patient experienced injection site lump and injection site bruising. On an unknown date, the outcome of the injection site lump and injection site bruising were unknown. The reporter considered the injection site lump and injection site bruising to be related to SHINGRIX. Additional details were reported as follows: The patient received the SHINGRIX in the left deltoid. The patient experienced a hard lump or knot at the injection site and the pharmacist described the lump or knot as being bigger than a penny and raised possibly 1 by 8th to 1 by 4th inches. Less than a day after receiving SHINGRIX, the site looked as if it was starting to bruise.
Abnormal heart rate starting 6 days after 1st vaccine.  Tachycardia & palpitations.  Pulse would range from 54 - 146 Previous PSVT  before becoming pregnant & it disappeared.  Normal sinus rhythm for 19 months until vaccine.   Other symptoms were full feeling head, tiredness & headache on right side of head, behind eye
Moderna booster administered 11/16/21, expired 11/7/21.  Mistakenly read expiration date as 11/17/21.  No adverse events or outcome to recipient.
he has lost also since he got that shot he had lost 8 pounds in like 4 days. He weighs not like a 117-118 pounds; Headache; His arm was hurting; It is the ringing in the ear; felt like a siren was going both of his ears; This is a spontaneous report from a contactable consumer (parent). A 38-year-old male patient (son) received first dose of BNT162B2 on 05Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were none. When he received the first one he felt headache a little bit and his arm was hurting and all of a sudden he suffers from tinnitus, It is the ringing in the ear. He is about 5' 9 and he has lost also since he got that shot he had lost 8 pounds in like 4 days. He weighs not like a 117-118 pounds. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.
This spontaneous case reported by a consumer, describes the occurrence of headache and vaccination site pain in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 001C21A) for COVID-19 immunization. No medical history reported. On Apr 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 20, 2021, patient experienced vaccination site pain. On May 17, 2021, patient experienced headache. On Apr 24, 2021, vaccination site pain resolved. At the time of the report, headache outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No treatment medications provided.
Initial report received from a health care professional on 09 Feb 2011: This patient received FLUVIRIN (batch number not reported) 0.5 ml, intramuscularly on Oct 2010. The patient was admitted to hospital and diagnosed with swine flu on 08 Feb 2011. No other information was provided at the time of this report.
(R) shoulder became sore on 12/16/16 - had pain with movement - no swelling redness or heat in deltoid or joint. Pt. seen on 12/30/16 - pain has decreased and had gained more ROM in joint - no deformity. Treated with 40 mg prednisone x 5 days.
'm post-menopausal, since March 2011 with no issues.  5-6 days after getting vaccination, I spotted very lightly, bleeding vaginally. It happened on and off, for two days then stopped.  No cramping or other symptoms.  When I read that this had happened to some patients, I thought I'd better report my occurence too.  No treatment or doctor visit necessary.  It was just a surprise .
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 41 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: "Anxiety" (unspecified if ongoing). Patient had no known allergies. There were no concomitant medications (Other medication in 2 weeks reported as no). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 and treatment included Paxlovid from 20Sep2022 to 25Sep2022.  The information on the batch/lot number for [BNT162B2] has been requested and will be submitted if and when received.
hip pain prior to the vaccine but it has become worse since getting the vaccine; CANNOT FOCUS; This case was reported by a pharmacist via call center representative and described the occurrence of arthralgia aggravated in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number EE924, expiry date 29th January 2022) and (batch number N4C23, expiry date 4th November 2019) for prophylaxis.   Concurrent medical conditions included pain in hip (had a very small amount of hip pain prior to the vaccine).   On 1st November 2019, the patient received the 2nd dose of Shingrix .5 ml. On 1st November 2019, the 2nd dose was .5 ml. In November 2019, less than a week after receiving Shingrix, the patient experienced arthralgia aggravated and concentration impaired. On an unknown date, the outcome of the arthralgia aggravated and concentration impaired were not recovered/not resolved.   It was unknown if the reporter considered the arthralgia aggravated and concentration impaired to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist stated that, after vaccination the patient had hip pain and was not able to focus. The patient had a very small amount of hip pain prior to the vaccine but it had become worse since getting the vaccine. The reporter stated that it was unknown, which hip had pain. The patient's arm felt good. There were two lot numbers listed because the pharmacist was not certain which one was correct. She strongly thought it was the EE924 but wanted to provide both just in case. The reporter consented to follow up.
Loss of speech and memory. Encephalitis, emergency room visit and inpatient stay, full recovery.
Swollen lymph nodes in left armpit and left neck. Ringing and pain in ears. Ear pain started 2 hours after vaccine. Swollen and painful armpit node started 1 day after vaccine.
Red, hot blotch on arm below injection site 5 inches long, 3 inches wide.
Hurt back; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BACK PAIN (Hurt back) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced BACK PAIN (Hurt back). The patient was treated with METHYLPREDNISOLONE ongoing since an unknown date for Back pain, at a dose of 7 day pack. At the time of the report, BACK PAIN (Hurt back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is not taking any concomitant medications.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 12-OCT-2015 09:43, the patient was vaccinated with improperly stored RECOMBIVAX HB with lot number: L016427, expiry date: 13-APR-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. The high temperature and low temperature were 11.2 and 1.6 respectively. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
Location of site:  At my job building.  Throbbing pain hasn't stopped.  Please help
Itchy rash; rash on my body / rash is in both arms and my chest and neck area; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (Itchy rash) and RASH (rash on my body / rash is in both arms and my chest and neck area) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN 81), PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and IBUPROFEN for an unknown indication.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH PRURITIC (Itchy rash) and RASH (rash on my body / rash is in both arms and my chest and neck area). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash) and RASH (rash on my body / rash is in both arms and my chest and neck area) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow up was received on 29-MAY-2021. Events- rash and rash pruritic outcome was updated to recovered/resolved.
Tetanus and Diptheria toxioid was given @ 0.5cc SC in place of a PPD injection. Area had increased swelling with warmth and tenderness that day. After 3 days of Levoquin 500mg, swelling, and tenderness had decreased, site where inj was administered is hard to touch and some skin sloughy.
Systemic: Exhaustion / Lethargy-Medium, Systemic: UNABLE TO STAND-Medium, Systemic: Numbness (specify: facial area, extremities)-Severe, Additional Details: PATIENT IS UNABLE TO STAND OR GET OUT OF BED TO USE BATHROOM
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, age group, race and ethnicity. 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, batch number: Unknown and expiry: Unknown) dose was not reported,1 total, administered on an unspecified date in Mar-2021 for prophylactic vaccination (Dose number in series 1). The batch number was not reported and has been requested. No concomitant medications were reported. On 15-Dec-2021, the patient experienced cough (confirmed covid-19 infection). On 16-Dec-2021, Thursday, the patient stated that he woke up in the morning with fever, fatigue, body aches. Patient took the home test twice (Laboratory test COVID-19 test), both the test reports were positive. The Patient went to medical facility and took another test there (it was a swab) (SARS-CoV-2 PCR test). The patient stated that he received text stating results were positive (confirmed clinical vaccination failure). At the time of reporting the patient stated he was at another facility (Emergency room) where he was awaiting treatment with monoclonal antibodies and he was not around anyone who has tested positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000207469.; Sender's Comments: V0:20211237727-covid-19 vaccine ad26.cov2.s- confirmed clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (an issue that happens when they vaccinated a person) in a  patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (an issue that happens when they vaccinated a person). At the time of the report, VACCINATION COMPLICATION (an issue that happens when they vaccinated a person) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medication provided.
Fever of 100.4 twenty-eight (28) after second dose. No fever with first.
Nausea with vomiting; pt stated a "hot flushed feeling" decrease loss of appetite, approx 24 hours more or less induration. By Sunday pm pt fully recovered without distress/ discomfort noted. No treatment noted throughout cause of signs/symptoms.
Pain in shoulder noted 10/07/14 and decreased range of motion noted 10/09/2014 along with severe pain.
Breaking out on neck and bald head, pt reports he put hydrocortisone and then later on noticed a saw rash on legs. Pt states his doctor is not open today so I advised he follow up with urgent care.
After second shot I had Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (After second shot I had Flu like symptoms) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 625C21A) for COVID-19 vaccination.     The patient's past medical history included COPD and Upper respiratory tract infection. Concomitant products included IBUPROFEN and FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY) for an unknown indication.    On 30-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (After second shot I had Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (After second shot I had Flu like symptoms) outcome was unknown. Not Provided          doctor advice patient to take dicyclomine 10mg, IB Guard before second short. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-068595 (Patient Link).
Chills; This case was reported by a consumer via call center representative and described the occurrence of chills in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th September 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 15th September 2021, 1 days after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was not recovered/not resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The patient experienced chills and asked how long the side effects typically last. The copy of package insert was offered.  The reporter did not consent to follow up. The reporter declined to provide health care professional information.
Patient took BENADRYL at bedtime and ZYRTEC during the day to combat the redness; pain, and rash that occurred during the reaction.
Before lunch time on 3-31-17 Mother called the health dept.  The child got up on 3-31-17 with a red rash covering neck, arms, legs and back. Encouraged to consult pcp and ER visit if mom felt necessary. Mom denied difficulty breathing or any other issue. I called mom at 3:40 pm and rash was improving. I called mom on 4-3-17 and mom reports rash was gone by 4-1-17.
skin started to burn; This spontaneous pregnancy case was reported by a consumer and describes the occurrence of SKIN BURNING SENSATION (skin started to burn) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.    Co-suspect product included non-company product NITROFURANTOIN for an unknown indication.    Concurrent medical conditions included Drug allergy (Nitrofurantoin) since 19-Dec-2020.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started NITROFURANTOIN (unknown route) at an unspecified dose. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced SKIN BURNING SENSATION (skin started to burn). At the time of the report, SKIN BURNING SENSATION (skin started to burn) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Treatment information was unknown.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Non-significant Follow-up
muscle spasms/along with cramps in upper and lower; severe pain in hands and feet; tingling that migrates all over my body; Numbness hands/ feet/losing feeling in my hands and feet; Numbness tongue; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness hands/ feet/losing feeling in my hands and feet), HYPOAESTHESIA ORAL (Numbness tongue), MUSCLE SPASMS (muscle spasms/along with cramps in upper and lower), PAIN IN EXTREMITY (severe pain in hands and feet) and PARAESTHESIA (tingling that migrates all over my body) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness hands/ feet/losing feeling in my hands and feet) and HYPOAESTHESIA ORAL (Numbness tongue). On an unknown date, the patient experienced MUSCLE SPASMS (muscle spasms/along with cramps in upper and lower), PAIN IN EXTREMITY (severe pain in hands and feet) and PARAESTHESIA (tingling that migrates all over my body). At the time of the report, HYPOAESTHESIA (Numbness hands/ feet/losing feeling in my hands and feet) and HYPOAESTHESIA ORAL (Numbness tongue) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment and concomitant medicines were not provided  Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Significant follow up
No s/e after first injection. After the second injection, I experienced chills, body aches, and a temp up to 102 within 18 hours of receiving the second dose. My symptoms continued most of the day but subsided mostly by 32 hrs. Day 2 after the second injection I continued to have pain in my left arm at the injection site. On the second day, the injection site also became very hot, red and swollen which lasted another 2 days  I took the day off from work on 2/3 but returned to work on 2/4
ear infections; This is a spontaneous report from a Pfizer sponsored program, from a contactable consumer or other non hcp.   A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on 18Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced ear infections on an unspecified date (wants to know will if affects the vaccine if she will take Amoxicillin). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
I had a bad sore throat with severe sinus pressure, congestion, chest tightness, coughing and tired. I also had pain on the left side of my neck. I am still recovering.