chrisvoncsefalvay/vaers-outcomes huggingface dataset:
sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concomitant products included TELMISARTAN, ROSUVASTATIN CALCIUM, DUTASTERIDE, ALFUZOSIN HYDROCHLORIDE, VITAMIN D NOS, ZINC and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No treatment medications were reported.   This case was linked to MOD-2021-330549, MOD-2021-330449 (Patient Link).
she should only get 2 doses of TWINRIX total; This non-serious case was reported by a consumer via call center representative and described the occurrence of off label use in a female patient who received HAB (Twinrix adult) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On an unknown date, the patient did not received Twinrix adult. On an unknown date, an unknown time after receiving Twinrix adult and an unknown time after receiving TWINRIX, the patient experienced off label use (Verbatim: she should only get 2 doses of TWINRIX total). The outcome of the off label use was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 28 June 2023 The case was reported by patient who received her first dose of TWINRIX. The reporter stated that her doctor said she should only get 2 doses of TWINRIX total.   As per insert stated that TWINRIX was a 3-dose standard or 4-dose advanced series.  The reporter did not consent to follow-up. The reporter stated that her doctor said she should only get 2 doses of TWINRIX total which led to off label use.
Patient became dizzy, shakiness, hypotensive ,, and pale in color. Noted initi40 [al B/P 87/ 40- pulse 86-givrn fluids to drink- blood pressure did not improve-continued to be dizzy. Nurse practitioner called to evaluate- instructed to continue with fluids and watch until vitals signs improve. After one hour client blood pressure came level out and improve at to 109/76 and pulse 83. Also the client was   given peanuts to each.. Client was observed for one hour. Family friend was called to take client home.
Pt experienced severe swelling, redness, heat rash, and induration from deltoid muscle to base of elbow
Seven days after the injection, a red raised welt began to form at the injection site. Overnight, the welt increased in size and ultimately reached a peak diameter of approximately 2 inches. It became warm and painful (pain scale 5/10).  I have a photo I can submit if desired.
Site swollen-cold compress, raised, redden, warm to touch, fever-TYLENOL.
Moderate to severe sore throat beginning on 01/12/2021 in the afternoon and lasting until 01/15/2021, low fever with chills starting the morning of 01/13/2021 and lasting until 01/14/2021, congestion of sinuses beginning on 01/14/2021 and lasting until the date of this report though improving.
Vaccine administered Thursday 9/21/17. Patient states symptoms started Saturday morning 9/23/17. Red at injection site. He also states he has a rash on "arms, legs, chest that is itchy and burns". Advised him to take BENADRYL, TYLENOL, and ice the injection site. I could not identify any rash on skin.
ELEVATED BLOOD PRESSURE; RUNNY NOSE; HEADACHE; TIREDNESS; This spontaneous report received from a consumer concerned a 62 year old male. 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 09-MAR-2021, the subject experienced headache. On 09-MAR-2021, the subject experienced tiredness. On an unspecified date, the subject experienced elevated blood pressure, and runny nose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the elevated blood pressure, runny nose, headache and tiredness was not reported. This report was non-serious.
expired IPOL was administered to patient, no AE; Initial information received on 08-May-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 12 years old male patient who received a 0.5 ml single dose of expired IPV (VERO) [IPOL] (lot: P1A242M, expiry date: 26-Apr-2020) via an intramuscular route in the left deltoid 05-May-2020 for prophylactic vaccination.  The patient's 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 did not experienced any 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.
This is in follow-up to report(s) previously submitted on 8/14/2007. Information has been received from a father concerning his 23 year old daughter with a history of cancer who in early 2007 was vaccinated with the first dose of 0.5 ml of Gardasil. The patient completed the three vaccination series of Gardasil (dates not reported). Concomitant therapy included tetanus toxoid and "other medications she has been on for a long time" (therapies were unspecified). Subsequently the patient's CA 125 levels increased from 14 to 24 over the four month period of treatment with Gardasil and the patient experienced anxiety. The patient sought unspecified medical treatment. At the time of the report the patient had not recovered. Additional information has been requested.
What Does it mean when you take the vaccine u get fever; What Does it mean when you take the vaccine u get chill; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (What Does it mean when you take the vaccine u get fever) and CHILLS (What Does it mean when you take the vaccine u get chill) 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 PYREXIA (What Does it mean when you take the vaccine u get fever) and CHILLS (What Does it mean when you take the vaccine u get chill). At the time of the report, PYREXIA (What Does it mean when you take the vaccine u get fever) and CHILLS (What Does it mean when you take the vaccine u get chill) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.                   No treatment medication was reported.
Pt developed hematoma left deltoid after Moderna vaccine.  Vital signs: BP 110/76, HR 64, RR 20, 96%O2Sat.  Pressure dressing applies to left deltoid.  recommended to patient to apply ice in 1 - 1 1/2 hours.  Patient discharged home with spouse.
Red warm swelling spot in injection side arm (right) that is warm to the touch and has traveled from injection site area.
The evening of the vax, the pt experienced a fever of 101 (rectal) which was treated with Tylenol and lasted three days. The most recent information received on 3/27/00 reports the condition of the pt is resolved.
Bad body aches for 24 hours, swelling pain and redness from shot injection site to elbow, hot to touch, still remains as of 11/16/16 but improving.
Client was vaccinated with a J &J vaccine. This was the clients first J &J vaccine. Upon reviewing inventory, the vaccine was beyond use date after client recieved it.
arm was hot to touch at injection site; red mark about 5 inches around injection area; injection site itching; A spontaneous report was received from a consumer concerning a 36-years-old, female patient who experienced arm was hot to touch at injection site, red mark about 5 inches around injection area and injection site itching.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 13 Jan 2021, approximately seven days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 027L20A] intramuscularly in the left upper arm for prophylaxis of COVID-19 infection.   On 20 Jan 2021, the patient stated that her arm was hot to touch with a big red mark about 5'' around injection site that extended to the middle of her arm. Also, the site was very red and itchy. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events arm was hot to touch at injection site, red mark about 5 inches around injection area and injection site itching were unknown.
Cramping at site of HPV vaccine then fainting.  Pale, low pulse.  Alert by time we entered room less than 1 minute.  Able to walk out of office in 10 minutes, alert, good color, good pulse and blood pressure.
I'm having pain in my right shoulder again.  I noticed minor pain after I had worked a couple of shift in early November.  When I got the H1N1 shot in my right shoulder.  I'm sure the nurse hit bone as I experienced pain like an electric shock that radiated to my hand.  That night I experienced spasms in my neck and shoulders and had great difficulty sleeping.  It subsided, but did not go away over the next couple of days.  I worked night shifts on November 10 and 17, then the three days of night shift November 25, 26 and 27.  By the time I completed those three nights it hurt to pick up a coffee pot and the spasms in my neck have restarted.  It is Tuesday December 1 and I am still in pain.
lethargy; urinary tract infection; vaccination site pain; tiredness; This spontaneous case was reported by a physician and describes the occurrence of LETHARGY (lethargy) and VACCINATION SITE PAIN (vaccination site pain) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced LETHARGY (lethargy) and VACCINATION SITE PAIN (vaccination site pain). At the time of the report, LETHARGY (lethargy) and VACCINATION SITE PAIN (vaccination site pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant drugs not reported.
Non injection side (right side of my body) around my neck, collarbone, right forearm, and right underarm all are sensitive to touch. My right cheekbone is also sensitive to touch. I have no physical rash or reaction on my skin. It?s all nerve feeling. The right side of my upper chest feels more tight than normal. With my history of spontaneous pneumothoraxes I usually have a good feeling on my lungs and chest. This feels tighter than normal and came on about 12 hours post vaccine shot. Otherwise I feel much better today than yesterday. This nerve feeling is still there however.
Blood dycrasias effecting hemoglobin decrease to 6? platelets decreased to 15, all blood cells were acutely decreased.
Mild chills and fever and then on/off migraines for over a week from the second shot.
Hives on upper arms, chest appeared 5 days after receiving shot for flu. No treatment. Follow up on 12/10/03: "
This spontaneous report has been received from a licensed practical nurse and refers to a 4 year old male patient. The patient had no known drug allergies. The patient was well nourished, alert, active, with normal tone and motor development, normal sensory system and reflexes and normal cranial nerves II-XII, but had ichthyosis. The patient's medical history included circumcision. After birth, the patient was in the NICU (neonatal intensive care unit) for 3 weeks. Patient had an innocent murmur with normal echocardiogram in 2013. On an unspecified date, between 29-AUG-2015 and 29-OCT-2015, the patient was vaccinated with improperly stored dose of PROQUAD 0.5, dose 1, (lot #K011311), on the left vastus lateralis. Patient was concomitantly vaccinated with KINRIX 0.5 on right vastus lateralis. The patient's other medications included fluoride, amoxicillin, albuterol, BACTROBAN, and LAC HYDRIN cream. No adverse effect was reported. This is one of several reports from the same report. Additional information has been requested.
Leg pain during the night.  Resolved in the morning. Left big toe numb the next morning.  Continues to today.  Have not seen the doctor yet, but I plan to.
It was reported that a 43 year old female received a Fluzone SV '99-'00 vaccination on 12/6/99. Reportedly, 2 days, post vax, the pt developed a purple rash on her legs from her ankles to her thighs. From additional information received on 1/13/00, it was reported that the pt recovered from this experience. Additional pt, vaccine and responsible physician information was also provided.
This spontaneous report was received from a medical assistant concerning a 17 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 24-JUL-2017, the patient was vaccinated with a dose of PROQUAD injection, lot number N013270, expiration date: 25-OCT-2018 (strength, route and dose were not reported) for prophylaxis. No adverse effects were reported.
5/6/04 Swelling from right deltoid to right elbow. Upper arm warm to touch. Referred to pediatric clinic for evaluation.  Nurse follow up on 06/18/04 states: "Erythema."
bad pain in her left wrist like arthritis; ringing in both ears; dull pain in her neck on the right side; inflammation (in her ear); pains in her breasts; Right ear felt like it was clogged; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (bad pain in her left wrist like arthritis), TINNITUS (ringing in both ears), NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)) and BREAST PAIN (pains in her breasts) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031m20a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced ARTHRALGIA (bad pain in her left wrist like arthritis), TINNITUS (ringing in both ears), NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)), BREAST PAIN (pains in her breasts) and EAR DISCOMFORT (Right ear felt like it was clogged). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. In February 2021, ARTHRALGIA (bad pain in her left wrist like arthritis) and TINNITUS (ringing in both ears) had resolved. At the time of the report, NECK PAIN (dull pain in her neck on the right side), INFLAMMATION (inflammation (in her ear)), BREAST PAIN (pains in her breasts) and EAR DISCOMFORT (Right ear felt like it was clogged) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. She was prescribed steroids in which she decided not to take but took Advil instead hoping that would help.
SORE LEFT ARM; STRONG HEADACHES; FEELS TIRED; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 2 diabetes, non smoker, and non alcohol user, and other pre-existing medical conditions included the patient did not have any history of drug abuse or illicit drug use. the patient had no known drug 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 09-MAR-2021 13:30 for prophylactic vaccination. No concomitant medications were reported. On 10-MAR-2021, the subject experienced sore left arm. On 10-MAR-2021, the subject experienced strong headaches. On 10-MAR-2021, the subject experienced feels tired. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore left arm on 2021, had not recovered from strong headaches, and the outcome of feels tired was not reported. This report was non-serious.
Initial report received on 08 September 2009 from another manufacturer, report # WAES0908USA04708 whose initial reporter was a health care professional. "Information has been received from a physician and an office manager concerning a 12 year old female patient with amoxicillin allergy who on 26-AUG-2009 was vaccinated with the first 0.5 ml dose of GARDASIL, concomitantly with a dose of (BOOSTRIX) (Lot : AC528046AA), a dose of VARIVAX (Lot : 664232/0498Y) and a dose of (MENACTRA) (Lot: U2815AA). The patient stated that after the vaccination she felt tired. She went home and had a seizure. the patient went to the emergency room and had computed axial tomography (CAT) done (results not reported). The patient was not hospitalized. The patient's mother called on 27-AUG-2009 at the physician's office and stated that her daughter was doing better. The physician also stated that her did not consider the events to be life threatening or to have caused the patient significant disability or incapacity. Upon internal review the seizure was considered as other important medical event. Additional information has been requested".
I received Pfizer for my first and second COVID19 vaccines and received Moderna for my booster shot. The evening of my shot (11/5/2021) I only experienced arm pain. The morning of 11/6/2021 I experienced arm pain, muscle and joint pain, headache, fever, and chest pain from movement.  On 11/7/2021 I went to a Clinic due to chest pain.  The provider did not believe I was having a cardiac issue but recommended I go to get an EKG to be safe. I went and they performed an EKG and the EKG results were normal.  As of 11/9/2021, I am still experiencing moderate chest pain from movement.
within 2 hours of the shot, throat swelled causing a panic attack.  After a few days the swelling did not go down so went to a convenient care down the road; was given antibiotics, inhaler and zyrtec.  After a week, muscles in arms started hurting.  Every week the pain became greater and traveled all over body including gums.  Local healthcare clinic agreed body was inflamed, gave steroid pack and made appointment with rheumatologist end of February 2020.  After one dose of the steroid, no pain at all.  Second pack was given to get me through the holidays. Within 24 hours after the last dose of steroid, pain and stiffness returned steadily.  I feel like my life has been ruined.
On 04/144/2021, I had pain from my arm to my leg, the pain proceeded to travel to my private area. I called the nurse line because I thought it was a kidney stone. The nurse called me back at 02:00pm and advised me to visit the Emergency room. I was evaluated at the emergency room, MRI, X-ray, BP was taken. The doctor suggested it was a possible STI and discharged me. I walked home and was still having pain in my private area. I went to seek care from my primary who stated I was misdiagnosed and had gout.
Headache, Myalgia, SkinRash, NauseaVomiting, chills, facial rashes Narrative:
Tested positive for covid after receiving the vaccine; Tested positive for covid after receiving the vaccine; This is a spontaneous report from a non-contactable consumer (patient's husband). A 44-year-old female patient (reporter's wife) received first dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK9231), via an unspecified route of administration in left arm on 29Dec2020 18:00 as single dose and second dose of BNT162B2 (Covid shot, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection Lot Number: EL3249), via an unspecified route of administration in left arm on 20Jan2021 14:00, both for covid-19 immunization. The patient had no relevant medical history and family medical history. There were no history of previous immunization with the Pfizer vaccine considered as suspect. The patient did not receive any concomitant medications. On 08Apr2021, the patient was tested positive for covid after receiving the vaccine. Reporter stated that his wife tested positive after she received the Covid 19 vaccine. The patient underwent lab test and procedures included covid positive on 08Apr2021. The outcome of event was not recovered.
tested positive for COVID 19; tested positive for COVID 19; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left, administration date 28Oct2021 (Lot number: FF8839) at the age of 24 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 05Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 15Jan2021 (Lot number: EL3247) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient had no prior COVID-19 vaccination. The patient had no known allergies. The patient was not pregnant at time of vaccination. Concomitant medication(s) included: BLISOVI FE; SERTRALINE HCL; LORATADINE; FLU VACCINE VII. The following information was reported: IMMUNISATION (medically significant) with onset 28Oct2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 28Dec2021, outcome "recovered" and all described as "tested positive for COVID 19". The patient underwent the following laboratory tests and procedures: Nasal swab: (28Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, COVID-19.
1/15/21-#1, soreness left upper arm, radiating to left upper back. Started morning 1/16/21 & lasted 3 days  2/9/21-#2, soreness left upper arm & left wrist, 30mins after injection.  2/10/21 Left shoulder very sore with limited mobility continual with increased soreness into evening & nighttime.  2/10/21 @ 6pm oral temp 100.3F & body "achiness" , took Ibuprofen 400mg with relief.  2/11/21- only slight discomfort L upper arm with movement, all other resolved.