chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sweaty; Horrible Headache; Entire body aches and pains; Specific Joint pain - finger joints and big toe joints; really bad soreness under her rib cage; spotting; Chills; Arm pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 46-years-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FC3184), via an unspecified route of administration on 29Aug2021 (Age at vaccination: 46-years-old) as second dose for covid-19 immunization. (Vaccination facility: Pharmacy) Vaccine was not administered at Facility. Medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medication included levothyroxine sodium (LEVOXYL) taken for hypothyroidism from an unspecified start date and ongoing (started 10 years ago). Historical vaccine included first dose of BNT162B2 (Batch/lot number: FA7485) on 09Aug2021 (Age at vaccination: 46-years-old) for Covid-19 Immunization. Did not receive additional vaccine on Same Date of the Pfizer Suspect. Prior vaccine within 4 weeks was reported as none. On 30Aug2021 patient experienced chills, horrible headache, entire body aches and pains, specific joint pain finger joints and big toe joints, really bad soreness under her rib cage, spotting on 31Aug2021 patient experienced sweaty. arm pain on 29Aug2021. It was reported she is supposed to report any adverse effects Pfizer. She needs to for her and her daughter. She is a Pfizer employee. She thinks phone is infected with a virus. She called and they said that someone was listening to them. She got her second dose and she didn't realize she was supposed to call for her first dose. She thought they were the regulars side effects. She had it on Sunday. 4:30 on Sunday she got the vaccine. She was fine until 12:30 and then she started getting chills. Chills: She thinks they are gone. She is still sweaty but she can get warm now. Treatment a blanket. Sweaty: In the middle of the night 31Aug2021, she was sleeping in the am. Not received treatment. Adverse events not resulted in Emergency Room and Physician Office visit. Patient received treatment for Arm pain, Really bad soreness under her rib cage, Specific Joint pain finger joints and big toe joints, Entire body aches and pains with Tylenol and Motrin and for event Horrible Headache treatment was Tylenol. For events Sweaty and spotting patient did not receive any treatment. The outcome for the event Chills, really bad soreness under her rib cage was resolved on 31Aug2021 For Sweaty, Arm pain, spotting outcome was not resolved And for Entire body aches and pains, Specific Joint pain finger joints and big toe joints outcome was reported as resolving and for remaining events outcome was reported as unknown at the time of this report.  ~ Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
A four year old with a history of prior Tetramune and DTaP immunizations, received a 5th dose of Tetanus and Diphtheria vaccine. Within 24 hours, she developed an 8 cm area of erythema, warmth, and tenderness. No signs of infection. Within 48 hours external reaction stabilized. No signs of infection.
19 yo previously healthy male presented with rash on left upper arm along with associated fevers and chills that he noticed on 11 Aug 16. On 4 Aug, patient reports getting a new tattoo on his left upper arm. The following day (5 Aug 16) he received the smallpox vaccine on the same arm as his new tattoo just beneath the tattoo site. On 11 Aug 16, he reported feeling ill and woke up on 12 Aug 16 with a rash over his new tattoo site. He reported having fevers, chills, nausea, HA with photophobia, and lower back pain. He described his HA as 3/10 Intermittent throbbing pain across his forehead mostly associated with fevers. His described his lower back pain as a dull pain in the middle of his lower back. He also reported neck pain that associated with his fevers and pain with neck flexion. He did not notice the rash on an any other areas on his body. He was feeling perfectly fine until 11 Aug 16. He denies any sick contacts or recent travel. He denies allergic reaction to any previous vaccines. ROS: 14 point review of systems negative except for above. Admitted to medical center on 12 Aug for vaccinia spread into recent tattoo. Received IV fluids and TYLENOL and Ibuprofen as needed, with significant improvement within 24 hours of admission, except for lesions within tattoos and additional lesions on abdomen and chest was. During hospitalization, existing lesions erupting, draining and by discharge, crusting. Afebrile at discharge.
This spontaneous report was received from an Office Administrator. The reporter stated that MMR II and (Merck) PROQUAD boxes look too much alike and may cause confusion. There was no note of any patient involvement. No adverse effect reported. Additional information has been requested.
PT ARRIVED TO THE E.R. DUE TO HAVING LARGE RASH TO LEFT FACIAL REGION AND FELT SICK POST 2ND MODERNA SHOT. DENIES SOB, CHEST PAIN, OR DIZZINESS AT THIS TIME. RECEIVED CLARITIN 10MG/ DECADRON 6MG IN THE E.R.
Pt vaccinated with Pneumococcal on 13NOV87 few hrs later developed respiratory distress seen in ER, mild wheezing; ABG PO2 of 108on room air given Epinephrine & Benadryl, developed temp 102, sweats, hives & cough productive of clear sputum.
Information has been received from a health professional and a 52 year old Caucasian male consumer with no known allergies and diabetes mellitus, stomach problems, cardiovascular disease and hypercholesterolemia and a history of a reaction to Trimax used in dental surgery and slight reaction to flu shots through the years who on 12/13/01, at approximately 11:45 am, was vaccinated in the right deltoid with pneumococcal vaccine 23 polyvalent (lot #641531/1352L). There was no illness at the time of vaccination. Concomitant therapy included atorvastatin calcium (LIPITOR), alprazolam (XANAX), atenolol, ranitidine hydrochloride (ZANTAC) and glipizide (GLUCOTROL). On 12/13/01, at approximately 13:30 pm, the patient called the local ER and they suggested using hot packs. It was reported that his seemed to make it worse and the upper arm continued to swell through 2/15/01. The second day, on 2/14/01, he called the health department and they suggested cold packs which seemed to help. There was no laboratory work done. It was reported that this lasted 2.5 days. The patient was unable to elevate his arm until 2/16/01. By 2/17/01 the patient reported the arm is normal. It was also noted that the patient had the influenza vaccine about a month and a half prior and did not have any reaction. Unspecified medical attention was sought.
but will not be able to because he is currently hospitalized for Pneumonia and a hear rate of 174.; but will not be able to because he is currently hospitalized for Pneumonia and a hear rate of 174.; This is a spontaneous report from a contactable consumer. An 84-year-old male patient (husband) received bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) first dose via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter was calling on behalf her husband who was scheduled to receive the 2nd dose of the Pfizer Covid vaccine on 19Mar2021, but will not be able to because he is currently hospitalized for Pneumonia and a hear rate of 174. Patient has been hospitalized since 14Mar2021. The patient received 1st dose "3 weeks ago". The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Scratchy throat, redness on tongue ~25 minutes post-vaccination. Assessed by medical director, given Zyrtec. ~90 minutes after vaccination, developed rash on chest.
A patient was administered with an expired dose of FLUZONE HIGH-DOSE QUADRIVALENT with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via consumer/non-health care professional via Medical Information (Reference number- 00784366) and transmitted to Sanofi on 24-Sep-2021.  This case involves a 71-year-old male patient who was administered with an expired INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (Expired product administered).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On 22-Sep-2021, the patient received a 0.7 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ483AB, expiry: 30-Jun-2021, formulation: solution for injection in pre-filled syringe) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of an actual medication error due to Expired vaccine used (latency same day).  No adverse event was reported.  It was reported "Caller stated that her office started giving this seasons FLUZONE high dose (HD) vaccines but a vaccine from last season was given of the 2020-2021 FLUZONE HD and she would like to know if the patients need to be revaccinated or what the process is now? Caller states Fluzone HD was given from last season, expired dose. She asks for follow-up. She clarifies, so it can be given again immediately."  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.
The patient received an underdose of the Pfizer COVID vaccine. The patient received the 2023-2024 COVID Pfizer vaccine formulation for those ages 5yo-11yo. The patient should have received the Comirnaty Pfizer COVID vaccine for those 12yo+. Follow up treatment is for patient to receive the correct dose of the Comirnaty Pfizer COVID vaccine for 12yo+. The patients parent has been contacted and given this information to receive the dose they need of the Pfizer COVID vaccine. No poor outcomes occurred, per the patients mother, from the patient receiving the Pfizer COVID vaccine for those ages 5yo-11yo 2023-2024 formulation.
Within 24 hours the pt developed a 10 cm area of erythema, edema and tenderness at the injection site. Mild Arthus-type hypersensitivity was diagnosed. 8 weeks later developed a mild reoccurrence and shooting pains at the site. Resolved with symptomatic therapy.
sudden lost hearing in right ear. waited 1 week  to see if cleared up with no change. Instilled debrox routine 4 days as recommended, thought it was a possible wax issue. ( do not typically have ear problems. usually my hearing is excellent.  Finally realized this occured just after covid vaccine.  Doctor appt  to follow
2nd dose way too late beyond the window time (42 days); This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose way too late beyond the window time (42 days)) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose way too late beyond the window time (42 days)). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose way too late beyond the window time (42 days)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
5-6 cm erythematous warm mildly tender patch at and below the injection site. No blistering.
Sudden cardiac arrest occurred 7 days post covid-19 booster. Was feeling heartburn-like symptoms a few hours prior to cardiac arrest. Resuscitated by paramedics and transported to the hospital for a week-long ICU stay. No known/identifiable cause of cardiac arrest. After numerous tests/imaging, heart structure found to be healthy and heart functions normally. ICD implanted to prevent future episodes of cardiac arrest since no cause was identified and no other treatment was appropriate.
I started to experience a sudden sore throat and coughing. Tested negative for COVID-19 and then went to the doctor. With in a short period of time I got bronchitis which continued to pneumonia that lasted for 1 month. Since then I have had a bacterial infection, a massive reaction to a medication to Cefalexin which was hives, throat swelling and itching that thrived for weeks. I had to get steroid injections. I also had a viral infection which tested negative for flu. I feel like my immune system has dropped since the vaccination.
Pain in the arm, headache, high fever, fatigue, first 24 hours Pain in arm at 48 hours Dizziness, fatigue 36 hours
Fever 102, vomiting, injection site red, swollen x 5 days.
Starting approximately 24 hours after shots he developed a red raised hives and swollen area on left thigh it measured 13cm in diameter with an area of 5 cm in diameter of slightly pale area around the DTaP site
Patient was tested for covid on 2/2/21 with positive resulted. Presented to Hospital ER on 2/10/21 with c/o of abdominal pain. Diagnosed with gastritis, prescribed metoclopromide and famotidine and dc home. Returned to ER on 2/13/21 with c/o of weakness, diarrhea, foot ulcer, and loss of appetite.  Diagnosed:   1) Dyspnea and hypoxia secondary to Covid-19 2) Extensive bilateral lung infiltrates secondary to Covid-19 3) Increased Cr 4) Increased LFTs, ferritin, d-dimer, troponin secondary to Covid-19 5) Elevated procalcitonin placing the patient at high risk for sepsis 6) Chronic appearing Right foot wound without signs of secondary infection Patient transferred to a different hospital in another city.
06:00 on 1/20/22, dizzy and lightheaded with sitting to standing, body aches all over. 13:30 heart rate 150-160 at rest, palpitations. Increased heart rate of 122-150 lasted 3-4 hours. 06:00 on 1/21/22 new symptoms noted. Injection site is sore. Swollen, tender lymph node in left armpit. All symptoms from 1/20 had resolved by 1/21. MD contacted and states to monitor the lymph node. If continues past 7 days, contact MD.
I had a huge red spot start to form a couple days after the shot. The delayed reaction was weird. It itched a little but it wasn?t particularly painful. My arm felt a little swollen & tender but I kept second guessing that because I was just so surprised. I didnt put anything on it and it didn?t prevent me from doing any daily activities so I didn?t contact my PCP about it. Eventually it wasn?t there or faded and it?s been 2 weeks since my first dose as of today (2/8/21).
Floaters and headaches seem to have gotten worse; They seem to be getting more frequent; Floaters and headaches seem to have gotten worse; They seem to be getting more frequent; Floaters and headaches seem to have gotten worse; They seem to be getting more frequent; This is a spontaneous report from two consumers. A contactable consumer (patient) and a non-contactable consumer reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration from an unspecified date at single dose for covid-19 immunization. The patient medical history included floaters and headaches. The concomitant medications were not reported. The patient had some predestined conditions of floaters and headaches but they either coincidentally or otherwise seemed to have gotten worse. They seemed to be getting more frequent since the patient had that that vaccine (Later clarified as Covid 19 vaccine Pfizer). The outcome of events was unknown.  Information on the lot/batch number has been requested.
RIGHT ARM HAS A 13CM RED IRRIATION & SWOLLEN. 4CM HAS WATER BUBBLES & DRAINAGE CLEAR. CENTER OF BUMP MEASURES 1CM PURPLE & RED. PT'S MOTHER WAS TOLD TO GIVE PT MOTRIN AND TRIAMCINOLONE ACETONIDE CREAM TO APPLIED ON INFECTED AREA.
Fever, chills, sweats, body aches, joint swelling, malaise, fatigue, headache, Left sided neck swelling with tenderness and erythema
pt recv vax;exp paresthesia, insomnia, nausea,anorexia, fatigue, HA and weakness;also devel fasiculations in all four extremities; CT scan, MRI, CBC, SED rate and chemistry tests were all nl; all events improved except for insomnia and N;
Fever of 101.5, chills, -body aches, stomachache, headache, high blood sugars 400-500 for 24 hours, sore throat, tired, and sore muscles.
Pain; 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 PAIN (Pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 PAIN (Pain). At the time of the report, PAIN (Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No treatment medications were provided.
Within 2 hours after injection arm became sore, hot, edematous. 11/10/2006 visualized edema, warm, red, indurated area 3 inches x 55 mm at site with welt-like raised areas pattern of band-aide previously on site.
I went to the the ER on 5/1 due to difficulties breathing.  They started me on an IV and did blood test.  I was in ketoacidosis and had low potassium and was in the hospital for 3 days. They gave me insulin.  I went to my NP on 5/11
Pt was discharged and began to have a headached, fever to 103.4, chills and feel dizzy. The area where the injection was began to look red and raised. CT of the arm was completed. He was treated with clindamycin IV.
Osteoarthritis; CARPAL TUNNEL; AFTER LAST BOOSTER SHOT ARM GOT HOT; AFTER LAST BOOSTER SHOT ARM WAS ITCHING; AFTER LAST BOOSTER SHOT ARM WAS SORE; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL), VACCINATION SITE WARMTH (AFTER LAST BOOSTER SHOT ARM GOT HOT), VACCINATION SITE PRURITUS (AFTER LAST BOOSTER SHOT ARM WAS ITCHING) and VACCINATION SITE PAIN (AFTER LAST BOOSTER SHOT ARM WAS SORE) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Crohn's disease.    Concurrent medical conditions included Crohn's disease (MODERATE TO SEVERE ADULT CROHN'S DISEASE).   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced OSTEOARTHRITIS (Osteoarthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL), VACCINATION SITE WARMTH (AFTER LAST BOOSTER SHOT ARM GOT HOT), VACCINATION SITE PRURITUS (AFTER LAST BOOSTER SHOT ARM WAS ITCHING) and VACCINATION SITE PAIN (AFTER LAST BOOSTER SHOT ARM WAS SORE). At the time of the report, OSTEOARTHRITIS (Osteoarthritis), CARPAL TUNNEL SYNDROME (CARPAL TUNNEL), VACCINATION SITE WARMTH (AFTER LAST BOOSTER SHOT ARM GOT HOT), VACCINATION SITE PRURITUS (AFTER LAST BOOSTER SHOT ARM WAS ITCHING) and VACCINATION SITE PAIN (AFTER LAST BOOSTER SHOT ARM WAS SORE) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 vaccine trial.  Concomitant medication and treatment information was not provided.  The reporter's causality for the event of osteoarthritis with Humira(adalimumab) was no reasonable possibility.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Patient states she has a knot between the injection site and her elbow.  The knot is about the size of an egg according to the patient's description.
The morning after vaccination, my husband developed sore arms that over the course of the day turned into sore muscles    over his entire body.  In addition he has extreme fatigue that interferes with daily activities.  He is normally a very physically active farmer.  He also has multiple loose stools daily.  This is his 6th day of feeling horrible.
rash underneath my arm; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: Unknown), via an unspecified route of administration as dose 1, single on an unspecified date for COVID-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced rash underneath arm. Patient had a question that, patient got vaccination, it's not where, it was where patient got the shot, it's just like underneath arm. It was in the middle of arm but it went away and now its kind of travelling up arm. Asked if it was one of the side effects with the rash, it's like a rash underneath arm. The patient does not take second dose as a kind of hesitant about getting second one and didn't know was it safe to take the second one since having this reaction. The patient was just kind of wondering that this was a normal side effect as how to and how much do with that. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Pt was administered vaccines on 5/2/06 and developed a red, blotchy rash and fever on 5/13/06. He was otherwise asymptomatic and treated conservatively with Tylenol.