chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lymph node inflammation of varying intensity causing intermittently sore throat when swallowing, tenderness to the touch, feeling of enlargement; also general sense or feeling of "being depleted"
Increasing tenderness at injection site, small hard spot and new shoulder joint pain  7 days after injection.  Shoulder pain increasing daily.
Rash started on 4-6-18 and started as itching, then rash on left arm, the both arms, then chest, then face and legs.
Patient complains of pain and soreness in the left arm and presents with a red rash on her bicep.
Patient received vaccination on 19 OCT at a mass immunizations, but dose was not fully given. Patient was fighting and the needle came out of the muscle prior to completion of vaccination given. It is estimated that the patient received half of the dose. Pt refused to receive the additional amount. Pt presented to immunizations clinic two days later on 21 OCT to receive the rest of the dose. Immunizations staff explained that further guidance would be needed before giving another dose. However parent of patient also showed immunizations corpsman the injection site from 19 OCT and the site appeared swollen and red. Patient was seen by provider the same day for evaluation. Cellulitis ruled out and patient was sent home with benadryl and return precautions. CDC guidance per Dr. is that if partial influenza dose is administered, a full dose should be administered if is done on another day. Patient educated by provider.
Red and swollen at injection site. Rash on lower arm- headache 1 week.Pain in arm for 2 weeks.
Painful swollen gland above left collarbone (superclavicular lymph node?) - felt like a hard sore lump. Stayed very sore for a few days and then pain gradually began to abate and swelling went down. It is 2 weeks later now and it still feels very slightly swollen, but is no longer painful. Did not seek treatment, but I did ask my pharmacist if it was a normal side effect or not. She said it was rare but not entirely unheard of.
new onset granulomatous polyangiitis  with  Acute renal failure, + CANCA, + proteinase 3, sinus disease, nasal ulcers, but bland UA
No adverse event.  This vaccine was indicated for 18 years and older.  Patient was under that age.
62 years old patient received a high dose flu vaccine, no AE; 62 years old patient received a high dose flu vaccine, no AE; Initial information received on 23-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 62 years old male patient who received a dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number and expiry date not reported) via unknown route in unknown administration site on an unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  At the time of the event, the patient had ongoing Chronic obstructive pulmonary disease.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  Documents held by sender: none.
Patient was mistakenly given dose of MenQuadfi that was meant for another patient. This is the patients 3rd dose of MCV4. Patient and parent were immediately made aware. No adverse effects noted.
There was an excursion from the freezer; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer). On 01-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Nov-2021: Added patient details(initials, age, gender) and vaccine information (dose number, date of vaccination).
Lots of fever (ER); Palpitation (ER); Arm was swollen (ER); Got very ill; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever, palpitation, swelling arm and illness. On an unknown date, the outcome of the fever, palpitation, swelling arm and illness were recovered/resolved.   The reporter considered the fever, palpitation, swelling arm and illness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 07-JAN-2023 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter was the patient. The patient got the vaccine and got very ill. The vaccine gave high fever, palpitations and arm was swollen.  The patient had to go to the emergency room and they stabilized to patient. The doctor told to patient as it was a vaccine reaction. The follow-up could not be possible as no contact details were available.
This spontaneous report as received from a Nurse refers to unspecified number of patients of unknown age. The reporter stated that M-M-R II, which might have gone out of range sometime in April 2013, but nurse was unable to provide the worst case time frame or temperature. The nurse additionally stated that an unspecified number of people have been administered this product. No adverse effects have been reported. Lot numbers and expiration dates unavailable for this product. On 10-JUN-2014, a phone call was placed to the nurse. The phone call was answered by other reporter. The reporter stated there was no one by that name at their facility/office. She checked with other nursing/office personnel concerning vaccine storage issues from April 2013. There was no information available to share with company concerning this report. This is one of several reports. The case is linked to 1309USA013801, 1406USA007117, 1406USA007119, 1406USA007120, 1406USA007121, 1406USA007076 (same reporter link). Additional information has been requested.
Pt. presented back to office 45 minutes after vaccinations of IPOL and DTaP for allergic reaction (hives and rash head to toe). O2 saturation 94% room air in room.
She immediately felt the needle go in. She felt the vaccine go in her deltoid. She felt some pain and she felt a sensation of the vaccine affecting her thumb. there was some numbness and pain in her thumb and deltoid lasting 8 days to date.
Chills; Diarrhea; Fever; I am not feeling well; This is a spontaneous report from a contactable consumer (patient).   A 79-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number, expiry date: Unknown), via an unspecified route of administration on 20Feb2021 (at the age of 79 year old) as dose 1, single for COVID-19 immunisation.  Medical history included high blood pressure and parkinson's disease from an unknown date. The patient was taking unspecified medications for high blood pressure and parkinson's disease. On 21Feb2021, afternoon, she was not feeling well, she had chills, diarrhea and little bit of a fever. The events resulted in clinic visit. The patient underwent lab tests and procedures which included on an unspecified date in 2021, SARS-COV-2 test, where result was found to be negative. The healthcare professional informed her, that it was a side effect from vaccination. Therapeutic measures were taken in response to the events included, Tylenol and drinking Gatorade. It was reported that, her second dose has been scheduled on 13Mar2021. At the time of report, the outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
a bit of a rash, like an allergy but not really bad; The injection site got itchy; The injection site got red; 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 VACCINATION SITE PRURITUS (The injection site got itchy), VACCINATION SITE ERYTHEMA (The injection site got red) and VACCINATION SITE RASH (a bit of a rash, like an allergy but not really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE PRURITUS (The injection site got itchy) and VACCINATION SITE ERYTHEMA (The injection site got red). On an unknown date, the patient experienced VACCINATION SITE RASH (a bit of a rash, like an allergy but not really bad). At the time of the report, VACCINATION SITE PRURITUS (The injection site got itchy), VACCINATION SITE ERYTHEMA (The injection site got red) and VACCINATION SITE RASH (a bit of a rash, like an allergy but not really bad) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter. Treatment included Claritin.   Reporter did not allow further contact
Patient felt faint approx. 2 minutes after administration of pneumovax vaccine. Pale, reported weakness, lightheaded, nausea, BP 80/60, HR 59, o2 sat 98% for approx 5-10 minutes. Administered oxygen 2L by nasal cannula. Rechecked BP 100/60, gave crackers and juice, pt responded well. Discussed side effects to monitor for at home w/mom. Pt ambulated w/out difficult, sent home w/mom.
PT RECIEVED PFIZER PRIME DOSE 01-08-2021 AND BOOSTER DOSE 01-29-2021. PCR/ANTIGEN AND IgG POSITIVE FOR COVID 19 DISEASE 08-11-2021
Dizziness, confusion, extreme agitation and heart racing. I felt like I was going to have a seizure as sounds were loud, and I felt like I was losing control of my body and mind! It lasted for almost 6 weeks. I couldn't look at my computer, phone, puzzle, books, tv or anything that made my eyes move as it made the dizziness worse. I was very foggy and lethargic for weeks afterwards with panic/agitation attacks. I HAVE NEVER HAD PANIC ATTACKS OR AGITATION LIKE THIS IN MY LIFE - IT WAS UNBEARABLE AND FRIGHTENING. My head was heavy, it felt like a weight was in it, it caused a broken blood vessel in my eye. I also had extreme pain in my big toe to the touch.
Unable to bear full weight. Fever, R thigh erythematous swelling --> Dx: R thigh myositis at site of injection, ultimate rebound with supportive cares. 9/4/09 Hospital records received DOS 6/25/09. Assessment: Myositis secondary to Pneumovax. Patient presents with inability to bear weight on (R) leg and foot. Hip held in external rotation, flexion of knee, mild swelling of thigh. Fever. Runny nose, cough. Fussy. Cafe au lait spots. tachycardia.  10/8/09 ICD-9 Codes received: 729.1 Myalgia and myositis unspecified, 518.89 Restrictive lung disease, 237.71 Neurofibromatosis Type I, V13.7 Hx prenatal problems, 780.60 Fever.  11/20/09 Duplicate med recs received from date 9/4/09.
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 37-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 37 years, in left arm 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 was not reported. Concomitant medication(s) included: AMLODIPINE; CITALOPRAM; HYDROCHLOROTHIAZIDE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN RESULT, notes: COVID 19 Treatment; POSITIVE, notes: Covid positive 20 days after recovery after paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Anti-viral details: Product-COVID 19 Treatment, Brand- Paxlovid, Treatment start date: 30Apr2022, Treatment stop date: 04May2022, Indication: Treatment of COVID-19.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine was not diluted, patient received all 6 doses in vial. Doctor, CDC and health dept notified. 48hrs after vaccine patient reported he had felt tired and weak. He stated his arm was very sore and he was not able to sleep on side d/t pain. Assessment of injection site was unremarkable.
Immediately after the shot patient screamed land all of sudden stop screaming like a light switch. And she got super pale. At 200pm patient Right side of face swelled. From cheek bone to eye.  She couldn?t open her right eye all the way. Not because it was swollen but it wouldn?t open.  4 days and nights following: extreme restlessness especially at night. Also seemed like she couldn?t hold her head up as she did prior
Information has been received from a nurse concerning a male who was vaccinated with the first and second doses of ROTATEQ.  Subsequently the patient threw up at home following the first dose.  Subsequently, the patient recovered.  After the second dose, the patient threw up.  The outcome was unknown.  Additional information has been requested.
Swelling burning, raw tongue, itching redness around 2nd days of receiving both doses
Expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered to patient) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. It was unknown if the patient experienced any symptoms.  No treatment medications was reported.
Achy, Myalgia, chills, headache, sore throat, hurt to open jaw.
On the day after my vaccine I was sweating all day but did not think anything of it.  By the end of the day I was not feeling myself, I went home and felt like I needed to rip my clothes off because I was so hot.  I was sweating but freezing at the same time.  I changed my clothes and went to bed.  I then began freezing where I my teeth were chattering and could not get warm.  I had on 3 blankets and was shaking.  I fell asleep and was having hallucinations and talking to my grandparents that are deceased.  I woke up not know anything but what I was told by my husband and daughter.  I took my temperature and it was 104.1.  I then continued to alternate between tylenol and ibuprofen for the rest of the night.  I slept from 6:00 pm the night of the 12th to 10:00 am on the 13th.  I still had a fever but developed a headache that nothing was helping.  my fever was 101.4.  I was told to go to the doctors to get checked by my job which I did, they examined me and the next day I went back for a COVID swab.  I was in bed for the next 12 days and everyday I was developing various symptoms.  By day 4 I had no taste and impaired smell and day 5-12 I had body aches, congestion and a cough that would not go away.  I was our of work from 01/12/21-01/25/21.
Pt described it as "covid arm". Hives at injection site a week after receiving vaccination. It healed in 3 days.
This was my second shot - I woke up the day after the injection with the same Spine/back muscle pain as I had last time with the first shot. The first shot back / spine pain Lasted over 3 weeks it resolved just prior to  getting the second shot. It felt as though I had injured my neck - back muscles even though I hadn?t.  This second shot I woke up with the same pain from them base of my head to my lower back - felt sore and injured even though I hadn?t injured my back. NEW symptoms occurred as well - had breast bone pain at the same time.  Brest bone pain lasted 1 day and resolved - back pain is ongoing but improved compared to last time   NEW SYMPTOMS - with second shot two days after I woke up with a swollen puffy face - lips and hands - I can?t fit my rings on. These symptoms are ongoing and my lips are tingling as well - I have never ha d any lip injections or face injections a- I?ve actually never done any derm things to my face but ha e and do  use a daily anti wrinkle topical  cream
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Mild, Systemic: Allergic: Rash (specify: facial area, extremeties)-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Pt complained of blurred vision and anxiety 15 min after injection.  After another 10 min, pt complained breathing was becoming difficult. She refused oral Benadryl.  I called 911.  Paramedics gave her IM Bendaryl. Pt refused to go to ER as symptoms had improved.  She waited an additional 20 minutes in pharmacy before going home.
Flu like symptoms, ER for Treatment at MC, elevated liver enzymes, 1 week later repeat labs and they had doubled. Admitted inpatient where levels continued to rise before beginning to decline after 2 days. Follow up testing included multiple GI tests and all were negative. Provider instructed, no cause identified and will default to influenza vaccine being cause.
Fever 101.7, chills, muscle pain, skin rashes, itching, fatigue
Right thigh red, swollen et tender to touch. Treatment Keflex 400/5ml 5ml TID x 10 days.
VERY ANGRY; NOT FEELING WELL; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced very angry, and not feeling well. The outcome of the not feeling well and very angry was not reported. This report was non-serious.
The day following booster shot I became unresponsive to all communications while being aggressively shaken and my name being repeated for several minutes while I was resting in my recliner.   Following this reaction I became very nauseated in the stomach and had the dry heaves for several minutes in front of my toilet!  The initial injection was more painful than I had expected and my right arm and shoulder still exhibits some discomfort.  I am a very active and physical 6'3" and 200 lbs in good health.
Generalized aching; Headache; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Generalized aching) and HEADACHE (Headache) in a 50-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) injection for Ankylosing spondylitis.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In May 2021, the patient experienced PAIN (Generalized aching) and HEADACHE (Headache). At the time of the report, PAIN (Generalized aching) and HEADACHE (Headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.
Severe (L) arm/shoulder pain skin sensitivity within 24hrs of vaccination. Tx: ice, NSAIDS, if persists Rx prednisone.
Immediately after injection I felt very dizzy and felt like chest was heavy. Episode lasted 5 min.  I then felt very dizzy and light headed the rest of the day and following day.
This case was reported by a healthcare professional and described the occurrence of wrong vaccine administered in a 4-month-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included DTAP, hepatitis B and IPV;GlaxoSmithKline;unknown;unknown given in July 2014. On an unspecified date, the subject received erroneously a dose of KINRIX (unknown) instead of PEDIARIX for the 2nd dose in series. Moreover, the subject was too young to receive KINRIX.
FLU LIKE SYMPTOMS; This spontaneous report received from a patient concerned a 74 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 08-MAY-2021 09:30 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAY-2021, the subject experienced flu like symptoms. Laboratory data included: Body temperature (NR: not provided) 97.5 F. The action taken with covid-19 vaccine  was not applicable. The outcome of flu like symptoms was not reported. This report was non-serious.
Severe chills, shaking and fever lasting 6 hours. Fatigue lightheaded dizziness vomiting next 2 days +