chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BURNING PAIN AT INJECTION SITE IMEDIATELY FOLLOWING THE DOSE.  THROAT STARTED TO CLOSE TIGHTEN UP BUT NOT COMPLETELY CLOSE 20 MINS AFTER INJECTION.  PAIN AT THE INJECTION SITE FOR 7 DAYS.  PAIN CONTINUES AT INJECTION SITE; PAIN TO LIGHT TOUCH OF THE INJECTION SITE.  INJECTION SITE TURNED RED AND BECAME SWOLLEN (HARD KNOT).  TODAY,  INJECTION SITE IS BURNING AND ITCHING.  SWELLING SUBSIDED SLIGHTLY AND THE INJECTION SITE REDNESS IS SPREADING ACCROS MY ARM.  THE CENTER OF THE SITE HAS TURNED BLACK.
1 day p/vax pt devel inj site rxn of redness,mild tenderness & hematoma. Tx w/warm compresses & benadryl.Rxn beginning to resolve as of Feb10,1998.
Initially redness and swelling on the arm of the injection. Followed by full body rash of the trunk, back, and neck. Ongoing symptoms as of time of report (11/17/2016). She did receive the flu vaccine on the same visit, but the symptoms started on the arm of the PNEUMOVAX.
vaccine totally leaked as it ran down on patient's arm and the floor and patient said she didn't feel anything going through her arm with no reported adverse event; Initial information received on 25-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 26 years old female patient who experienced rabies (HDC) vaccine [Imovax Rabies] vaccine totally leaked as it ran down on patient's arm and the floor and patient said she didn't feel anything going through her arm with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 25-Aug-2023, the patient received a dose of 1.0 ml once of suspect rabies (HDC) vaccine (Powder and solvent for suspension for injection) (lot: V1D882M; expiry date: 20-Sep-2024; strength: standard) via unknown route in the left deltoid for Immunization and vaccine totally leaked as it ran down on patient's arm and the floor and patient said she didn't feel anything going through her arm with no reported adverse event (accidental exposure to product) (unknown latency).  It was reported, "Public Health Nurse was administering IMOVAX to a patient but the vaccine leaked around the hub of the syringe they prepared. Nurse added that the hub is kind of offset a little bit and there's bubbles in the hub area of our syringe."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the 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 the guidelines. 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.
FELT SUPER HOT/ SWEATY; PAIN FROM ARM TO NECK; FELT LIKE LITTLE NEEDLES ALL OVER BODY; GOT A TINY BUMP THE SIZE OF A PEANUT  BETWEEN NECK AND SHOULDER; ARM SORE; HEADACHE; This spontaneous report received from a patient concerned a 47 year old of unspecified sex. 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: 205A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 24-JUL-2021 for prophylactic vaccination. No concomitant medications were reported.  On 25-JUL-2021, the subject experienced felt super hot/ sweaty. On 25-JUL-2021, the subject experienced pain from arm to neck. On 25-JUL-2021, the subject experienced felt like little needles all over body. On 25-JUL-2021, the subject experienced got a tiny bump the size of a peanut between neck and shoulder. On 25-JUL-2021, the subject experienced arm sore. On 25-JUL-2021, the subject experienced headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from pain from arm to neck on 01-AUG-2021, and got a tiny bump the size of a peanut between neck and shoulder, and was recovering from arm sore, headache, felt super hot/ sweaty, and felt like little needles all over body. This report was non-serious.
Information has been received from a 69 year old female patient referring to herself who was with egg allergy. The patient's medical history included gall bladder removed at unspecified date. On 18-JAN-2016 the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot# not reported). Concomitant therapies included unspecified aspirin dose. On 19-JAN-2016 the patient experienced chills, headache, fever, fatigue and constant nausea. She took an unspecified dose of TYLENOL as treatment. Lab diagnostics studies were not performed. The patient did not seek medical attention. The therapy of PNEUMOVAX 23 was not reintroduced. The events were improved and the outcome of all the events was recovered on an unspecified date in 2016. The causality was not reported. Additional information is not expected as there is no consent for follow up.
Initial and follow up information has been received from a physician concerning an 18 year old female patient, with a suspected strep infection on 27-MAR-2007 ("two weeks prior"), who on 09-APR-2007 was vaccinated with the third dose of Gardasil (route and dose not specified). The physician reported that after receiving Gardasil, the patient experienced arthralgia (date not specified). The physician reported that the following diagnostic testing had been performed (dates not specified), antistreptolysin (ASO), elevated, C-reactive protein (CCRP), elevated antinuclear antibodies test (ANA), minimally elevated; erythrocyte sedimentation rate, negative, rheumatoid factor, negative; and testing for Lyme disease, result pending. Patient outcome was unknown, as the physician was unable to contact the patient. Additional information has been requested.
c/o headache - tylenol 2 tabs given po; Later up again about 1/2 hr walked into wall, tremors, dropped to knees, sz;
Fever 102.6, rash with red/erythematous macule and single vesicle.
Burning Pain in Right arm, back of neck and under arm day after shot which lasted a couple of days. Neck pain went away but arm pain and underarm pain continued and became progressively worse.  Went to ER when pain was unbearable. Had X-rays and bloodwork done by ER and PCP to ry and determine cause of pain. Was sent to Orthopedic for evaluation and was determined it was SIRVA. Sent for physical therapy.
Patient said vaccination was more painful than other vaccines she had taken. The pain decreased a little over the next few days, but persisted after weeks. Enough that patient went to her primary doctor and was diagnosed with sirva.
After recieving the 1st injection at approximately 0900 on 5/2/08 patient had low grade fever of 100.6, myalgias, upper respiratory system symptoms that rapidly progressed to exacerbation of asthma by 4pm which required being evaluated by pulmonologist within 24 hours of injection.  Patient received antibiotics, initiation of Advair Diskus prescription, burst of steroids, Veramist, change of nebulizer meds to Xopenex and increase in frequency of inhaled nebs.  Patient had to be re-treated less than 3 weeks later after relapse after completing antibiotic and steroid therapy.  Patient is now on maintenance doses of Advair diskus, Veramist and back to using Albuterol for rescue inhaler use.
Pain, redness, itching, and swelling at injection site. Redness about 3? diameter. Swelling about 4? diameter and raised about 1/2 inch.
Patient received two vaccines in the same arm separated by an inch apart. A few hours after administration he said he had a sore arm and a knot about the size of a quarter. By the end of the night the knot grew larger. The next day of about 24 hours after administration the patients arm on the area of administration was swollen, red, hot to the touch, tender, and about 6 inches wide. The patient will follow-up with his doctor.
Soreness/stiffness in neck and shoulder blades. Pt stated they experienced the same effect after the flu shot last year. No problem with previous other doses. Pt is complaining of excruciating pain and soreness in her neck when she swallows, muscular pain. ADVIL helps, but does not relieve pain.
swollen lymph node in her left axilla/lymphadenopathy; pain in her left axilla; able to palpate a swollen lymph node in her left axilla; This is a spontaneous report from a contactable physician (the patient). A 28-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EJ1685), intramuscularly in the left arm on 17Dec2020 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunization. There was no medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included famotidine and fexofenadine hydrochloride (ALLEGRA), both for unknown indications from unknown dates and unknown if ongoing. The patient previously took and had an allergy to amoxicillin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 23Dec2020 at 13:00, the patient developed pain in her left axilla (6 days after vaccination). The patient was able to palpate a swollen lymph node in her left axilla. It continued to become more painful requiring ibuprofen and hot compresses. By 31Dec2020, her symptoms had largely resolved. She saw her physician who also felt the lymphadenopathy and had no other explanation than possible vaccine side effect. The clinical outcome of pain in her left axilla, swollen lymph node in her left axilla/lymphadenopathy, able to palpate a swollen lymph node in her left axilla was recovered on 31Dec2020. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
About 3 1/2 weeks after the booster I began to feel weak tired and a lot of nausea. I called a HCF to let them know and they told me to come in for bloodwork. When I get symptoms of any kind my oncologist has me come in to get checked because of the cancer that I have. I am off for 7 days off of cancer meds right now. I scheduled my booster on August 21, during the time I was on my 7 day off of Revlimid.
Breakthrough case admission after 2 vaccines Pfizer 11/27/21 Lot# 33030BD;  Pfizer 12/18/21 Lot# FE3594
brain fog; vertigo; could not stand; feeling sick; headache; vomiting; could not open her eyes; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (could not open her eyes), FEELING ABNORMAL (brain fog), VERTIGO (vertigo), DYSSTASIA (could not stand) and MALAISE (feeling sick) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced SOMNOLENCE (could not open her eyes) and FATIGUE (fatigue). On 28-Feb-2021, the patient experienced FEELING ABNORMAL (brain fog), VERTIGO (vertigo), DYSSTASIA (could not stand), MALAISE (feeling sick), HEADACHE (headache) and VOMITING (vomiting). The patient was treated with METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) ongoing since an unknown date at a dose of 1 dosage form and CLONAZEPAM (KLONOPIN) ongoing since an unknown date at a dose of 1 dosage form. On 08-Feb-2021, SOMNOLENCE (could not open her eyes) and FATIGUE (fatigue) had resolved. At the time of the report, FEELING ABNORMAL (brain fog), VERTIGO (vertigo), DYSSTASIA (could not stand), MALAISE (feeling sick), HEADACHE (headache) and VOMITING (vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Myalgia, Arthralgia, Fever, 100.1 fever. extreme fatigue Narrative:
Headache after injection, itchy bump/rash on injection site 1 week after first dose
This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 6th June 2018, refer case US2018103117 for 1st dose). On 31st December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 31st December 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and tremor. On an unknown date, the outcome of the chills, fever and tremor were recovered/resolved. It was unknown if the reporter considered the chills, fever and tremor to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX on the left arm. The patient received their 2nd dose of SHINGRIX which was later the recommended schedule, which led to lengthening of the vaccination schedule. After vaccination, the patient experienced chills, fever and shaky. The reporter gave consented to follow up.
Per the employee/patient : On November 16th, I received the flu vaccine in my left shoulder. Immediately as the flu vaccine went in I experienced pain. I experienced pain every day since then. I tried ice compresses, warm heat, NSAIDS, advil , motrin and alleve and have not had any relief. I continue to have a moderate amount of pain on a daily basis, immobility , left scapula pain and difficulty with range of motion abilities. This incident occurred 10 weeks ago, and has not resolved. For the last 10 weeks, I have attempted multiple treatment modalities without success. Now, I have recognized the need to seek further evaluation since it is interfering with my job capabilities.
Information has been received from a registered nurse concerning a female patient who on an unknown date was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot# not provided). Subsequently, it was reported that the patient felt faint post vaccination. The patient sought unspecified medical attention.  At the time of this report, it was unknown if the patient had recovered from the event.
No additional AE; multiple temperature excursions/multiple doses of ROTATEQ were administered to multiple patients; This spontaneous report was received from an office administrator referring to an infant male patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 08-NOV-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1661000, expiration date 13-MAY-2021, at a dose of 2 milliliter once, orally for prophylaxis. There were multiple temperature excursions (temperature values and time frames were not reported) recorded by a data logger. No addtional adverse event reported.   This is one of several reports received from the same reporter.
Localized swelling & redness at injection site. Cold compress was applied. Swelling & redness resolved by 5th day.
I was positive for COVID-19 on 11FEB2023, I had a lot of sinus drainage, coughing, congestion and chills. I did not have a fever, I was sick for about 2 weeks. I contacted my doctor and he prescribed me Paxlovid. I started feeling better about 2 weeks after Paxlovid, now I feel good.
Constant heartburn-like chest pain for two weeks now. Treated with Omeprazole 10 days, didn?t help. Switched to Famotidine, seems to be improving.  Whole body skin sensitivity started same time as heartburn pain, itchiness and symptoms like dermatographia. Itchiness has improved with Zyrtec.
Respiratory illness 1 week after vaccine. Transported to hospital 10/31/11. Remains hospitalized to date.
several pt from this site devel an inj site rxn following vax;no further info was available @ the date of this report;
Patient brought by ambulance accompanied by family members for evaluation of fever, not feeling well.  Family member stated that the patient started acutely not feeling well just this evening.  Patient just generally states she does not feel well, and family states she has been having chills, fever, appearing like she is having some difficulty breathing.  She has not had any vomiting or diarrhea.  She has chronic urinary incontinence with UTIs, on antibiotics.  She received her COVID-19 booster shot at 9:30 AM in the morning. Patient was tachypneic, tachycardic and febrile upon arrival was made a sepsis alert. Patient had an improvement in her heart rate, blood pressure and fever here in the emergency department.  She overall was starting to feel better.  Felt this is most likely a reaction or response to her COVID-19 booster.  Given her MS and overall appearance however would recommend admission for continued observation. Discharged in stable condition.
got shot probably around 1130AM; high pitched screaming & breath holding from 430PM until 930PM solid; no temp; leg seemed sore; used APAP q 4 hr & compresses to legs; fell asleep @ 930PM & slept all noc & seemed fine when awoke next day;
cannot walk; cannot move at all; no control of balance; barely talk; slowly getting scared; numbness/numbness started on the right side and moved to the left; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT INABILITY (cannot walk), MOBILITY DECREASED (cannot move at all), BALANCE DISORDER (no control of balance), SPEECH DISORDER (barely talk) and FEELING ABNORMAL (slowly getting scared) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 031B21A and 004C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus (But pretty much healthy working construction).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced GAIT INABILITY (cannot walk), MOBILITY DECREASED (cannot move at all), BALANCE DISORDER (no control of balance), SPEECH DISORDER (barely talk), FEELING ABNORMAL (slowly getting scared) and HYPOAESTHESIA (numbness/numbness started on the right side and moved to the left). The patient was treated with Physical therapy for Gait inability; Physical therapy for Mobility decreased; Physical therapy for Balance disorder; Physical therapy for Speech disorder; Physical therapy for Feeling abnormal and Physical therapy for Hypoaesthesia. At the time of the report, GAIT INABILITY (cannot walk), MOBILITY DECREASED (cannot move at all), BALANCE DISORDER (no control of balance), SPEECH DISORDER (barely talk), FEELING ABNORMAL (slowly getting scared) and HYPOAESTHESIA (numbness/numbness started on the right side and moved to the left) outcome was unknown.            No concomitant medications were reported.  The reporter feel like they were losing patient little by little. Reporter reported that the patient been to doctors and been to a medical hospital and the numbness started on the right side and moved to the left.  No treatment information was reported.
early stages of pericarditis or the shingles; severe chest pain; early stages of pericarditis or the shingles; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EL1283, unknown expiration), via an unspecified route of administration in left arm on 13Jan2021 at 13:00 (01:00 PM; at the age of 48 years old) at a single dose for COVID-19 immunisation.  Medical history reported as none.  There were no concomitant medications. The patient has no known allergies. The patient also received first dose of BNT162B2 (Brand: Pfizer; Lot number: EJ1685, unknown expiration) on 23Dec2020 at 01:00 PM in left arm (at the age of 48 years old) for COVID-19 immunization. The patient went to the ER with severe chest pain. After many tests were run, doctors believed that the patient was in early stages of pericarditis or the shingles on 17Feb2021 at 04:00 AM. The patient confirmed that she never developed shingles but have had all symptoms of pericarditis. The events resulted in emergency room/department or urgent care visit. The patient received NSAIDs and pain meds as treatment for the events. The patient had no COVID prior to vaccination and was not tested for COVID post vaccination. The patient did not receive other vaccine in four weeks.  The patient is recovering from the events.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, the Company considers the reported event pericarditis is unrelated to BNT162B2 vaccine, but more likely an inter-current medical condition. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
After all three vaccines I had a sore arm that got worse for like 3 days, then a migraine for almost a week. I had to get a new prescription for the migraine because my current one was not working. With the first two I had fever of about 102 degrees or something like that, but not with the third. I also slept a lot like 14-16 hours. 04/17/2022 I was diagnosed with COVID-19, my shoulder hurt really bad that day, I had a fever and my shoulder had the feeling of achy muscles into my bones, I also had a migraine and a little bit of a horsed throat and that was about it. Outbreak of COVID-19 also on 12/14/2021, and August or September of 2021. My first vaccine was January 2021. I would also like to mention that with all three I had really bad night sweats. I was not able to get my booster on time because I went into anaphylactic shock over my allergy injections so I had to wait to get the booster.
Had a sore arm the night of  the vaccine.  Woke up the next morning  feeling a little fatigued.  Body started hurting at around 11 am, like someone used me as a punching bag.  Left work early and took a nap, the body pain went away, but then developed a fever of 102.  Took some Tylenol. Continued with a fever of 102-100.1  overnight.  Fever broke around 10 am on Friday 2/5/21 and feel much better.
On day 13 following injection, my left arm at the injection site became itchy, red, and swollen (Covid Arm). It lasted for three days and went away. Otherwise, I felt fine. I had my second shot on 2/18/21 in my right arm (Moderna, batch 011M20A) and could barely lift my arm after about four hours for the remainder of the day. Then on day one after the shot, I had the same Covid Arm reaction - itchy, red, and swollen arm. It is now day three and my arm is getting better.